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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
NCT ID:
NCT02163694
Description:
None
Frequency Threshold:
5
Time Frame:
All-cause mortality were reported from enrollment to the end of study, median time on follow up was 84.5 and 81.8 months for Placebo + C/P and Veliparib + C/P, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 115.0 and 117.5 days for Placebo + C/P and Veliparib + C/P, respectively.
Study:
NCT02163694
Study Brief:
A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer
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 + C/P | Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21- day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle. | 129 | None | 68 | 174 | 169 | 174 | View |
| Veliparib + C/P | Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle. | 244 | None | 135 | 339 | 332 | 339 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| HAEMORRHAGIC DISORDER | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| CARDIO-RESPIRATORY ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| CARDIOPULMONARY FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| PERICARDITIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.0 | View |
| DIPLOPIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| RETINAL ARTERY OCCLUSION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| ABDOMINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| COLITIS MICROSCOPIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| FAECALOMA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| ILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| NONINFECTIVE SIALOADENITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| PANCREATITIS ACUTE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| DISEASE PROGRESSION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| HYPERTHERMIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| ANAPHYLACTIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| CONTRAST MEDIA ALLERGY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| DRUG HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| ABSCESS JAW | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| BREAST CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| BRONCHITIS MORAXELLA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| DEVICE RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| DEVICE RELATED SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| GASTROENTERITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| INFECTED DERMAL CYST | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| INFECTED LYMPHOCELE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| MENINGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| MYELITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| NEUTROPENIC INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| NEUTROPENIC SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| OPHTHALMIC HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| PAROTID ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| RESPIRATORY TRACT INFECTION VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| STAPHYLOCOCCAL SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| VASCULAR DEVICE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| ELECTROLYTE IMBALANCE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| GOUT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| JOINT LOCK | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| OSTEONECROSIS OF JAW | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| SPINAL STENOSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| ACUTE MYELOID LEUKAEMIA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| CANCER PAIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| COLON CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| GASTRIC NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| MALIGNANT NEOPLASM PROGRESSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| MALIGNANT PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| METASTASES TO BONE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| METASTASES TO BONE MARROW | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| METASTASES TO CENTRAL NERVOUS SYSTEM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| METASTASES TO LYMPH NODES | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| METASTASES TO MENINGES | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| MYELODYSPLASTIC SYNDROME | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| SECOND PRIMARY MALIGNANCY | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| TUMOUR PAIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| APHASIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| BRAIN OEDEMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| CERVICAL CORD COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| DYSARTHRIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| HYDROCEPHALUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| INTRACRANIAL PRESSURE INCREASED | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| MENINGEAL DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| PARTIAL SEIZURES | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| PRESYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| SCIATICA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| VASCULAR ENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| DEVICE BREAKAGE | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 26.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| MANIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| PSYCHOTIC DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| CHRONIC KIDNEY DISEASE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| PELVIC PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.0 | View |
| ATELECTASIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| LARYNGEAL OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| PLEURITIC PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| PNEUMOMEDIASTINUM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| PULMONARY ARTERY THROMBOSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| ANGIOEDEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| ABORTION INDUCED | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 26.0 | View |
| AORTIC STENOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| ILIAC ARTERY OCCLUSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| POOR VENOUS ACCESS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| PALPITATIONS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| TINNITUS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.0 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.0 | View |
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| PERIPHERAL SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| DRUG HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.0 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| RESPIRATORY TRACT INFECTION VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| HYPOPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| TASTE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| BREAST PAIN | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| RHINORRHOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| HOT FLUSH | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| LYMPHOEDEMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |