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 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
NCT ID:
NCT02287233
Description:
All-cause mortality is reported for all enrolled participants. Adverse events are reported for all participants who received at least 1 dose of venetoclax.
Frequency Threshold:
5
Time Frame:
All-cause mortality is reported from enrollment through the end of study; maximum time on study was 63.7 months. Adverse events are reported from first dose of study drug until 30 days after last dose of study drug; median (minimum, maximum) duration of treatment was 4.1 (0.2, 62.8) months overall.
Study:
NCT02287233
Study Brief:
A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase 1: 600 mg Venetoclax + LDAC | Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met. | 6 | None | 7 | 8 | 8 | 8 | View |
| Phase 1: 800 mg Venetoclax + LDAC | Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met. | 10 | None | 9 | 10 | 10 | 10 | View |
| Phase 2: 600 mg Venetoclax + LDAC | Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met. | 63 | None | 68 | 74 | 74 | 74 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (24.0) | View |
| LARGE INTESTINE POLYP | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| GAIT DISTURBANCE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| DIVERTICULUM INTESTINAL HAEMORRHAGIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| HEPATIC FAILURE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (24.0) | View |
| PSYCHOTIC DISORDER DUE TO A GENERAL MEDICAL CONDITION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| HAEMOLYTIC ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| ACUTE CORONARY SYNDROME | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| SINUS BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| SUPRAVENTRICULAR TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| DIPLOPIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| GASTROINTESTINAL DISORDER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| HAEMORRHOIDAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| INTUSSUSCEPTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| LARGE INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| LARGE INTESTINE PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| DEVICE RELATED THROMBOSIS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| DISEASE PROGRESSION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| HYPERPYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| SUDDEN DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| ACUTE HEPATIC FAILURE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (24.0) | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (24.0) | View |
| CHOLECYSTITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (24.0) | View |
| BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| BACTERIAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| BRONCHOPULMONARY ASPERGILLOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| CANDIDA PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| DEVICE RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| ESCHERICHIA BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| ESCHERICHIA SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| ESCHERICHIA URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| INFECTIOUS PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| LARGE INTESTINE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| NOSOCOMIAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| OSTEOMYELITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| PARAINFLUENZAE VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| PNEUMONIA KLEBSIELLA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| PULMONARY SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| RESPIRATORY TRACT INFECTION FUNGAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| SERRATIA SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| UPPER RESPIRATORY TRACT INFECTION BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| VASCULAR DEVICE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| INTENTIONAL OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| POST-TRAUMATIC PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| SKIN LACERATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| SPLENIC RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| SUBDURAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| AMYLASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| LIPASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| TROPONIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| WHITE BLOOD CELL COUNT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| FAILURE TO THRIVE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| FLUID OVERLOAD | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| BURSITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| OSTEONECROSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| MALIGNANT NEOPLASM PROGRESSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | View |
| CEREBRAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| DEMENTIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| HAEMORRHAGE INTRACRANIAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| HAEMORRHAGIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| ISCHAEMIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| LACUNAR INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| PRESYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| SUBARACHNOID HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| MENTAL STATUS CHANGES | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| LUNG DISORDER | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| PLEURITIC PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| PULMONARY ALVEOLAR HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (24.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| HYPOFIBRINOGENAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| ANGINA PECTORIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| HYPERTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (24.0) | View |
| ERYTHEMA OF EYELID | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| EYE PAIN | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| RETINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| ERUCTATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| GASTROINTESTINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| LIP ULCERATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| MOUTH HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| MOUTH ULCERATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| ODYNOPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| PARAESTHESIA ORAL | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| TONGUE HAEMATOMA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| TRICHOGLOSSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| CATHETER SITE INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| CATHETER SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| CHEST DISCOMFORT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| DEVICE RELATED THROMBOSIS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| INJECTION SITE HAEMATOMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| BRONCHOPULMONARY ASPERGILLOSIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| CLOSTRIDIUM DIFFICILE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| DEVICE RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| ESCHERICHIA URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| HERPES SIMPLEX | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| HORDEOLUM | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| ORAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| PARONYCHIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| SIALOADENITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| HEAD INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| INFUSION RELATED REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| PERIORBITAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| SUNBURN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| TOOTH FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| WOUND | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| BLOOD ALBUMIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| BLOOD LACTATE DEHYDROGENASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| BLOOD URIC ACID INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| HEART RATE IRREGULAR | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| INTERNATIONAL NORMALISED RATIO INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| LIVER FUNCTION TEST ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| LIVER FUNCTION TEST INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| LYMPHOCYTE COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| PROTHROMBIN TIME PROLONGED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| SPECIFIC GRAVITY URINE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| TROPONIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| FLUID OVERLOAD | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPERMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPERPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPERURICAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPOALBUMINAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPOCHLORAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPOGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| HYPOPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| TUMOUR LYSIS SYNDROME | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| CHONDROCALCINOSIS PYROPHOSPHATE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| GROIN PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| JOINT SWELLING | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| LIMB MASS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| CEREBRAL MICROANGIOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| RESTLESS LEGS SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| SINUS HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| TASTE DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| DELIRIUM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| FLAT AFFECT | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| HALLUCINATION, VISUAL | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| MOOD ALTERED | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| PROCEDURAL ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| RESTLESSNESS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| SLEEP DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| POLLAKIURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| ATELECTASIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| PLEURITIC PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| PRODUCTIVE COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| RESPIRATORY DISTRESS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| RESPIRATORY TRACT CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| NAIL DISCOLOURATION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| PETECHIAE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| PURPURA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| RASH ERYTHEMATOUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| RASH MACULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| RASH PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| SKIN LESION | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| STASIS DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| HAEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (24.0) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (24.0) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (24.0) | View |
| MACROANGIOPATHY | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (24.0) | View |