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:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
NCT ID:
NCT00048932
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00048932
Study Brief:
A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Open Label (OL) Abatacept | Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period. | None | None | 425 | 1184 | 1010 | 1184 | View |
| Abatacept (ABA) | Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for subjects \< 60 kg, 750 mg for subjects 60 to 100 kg and 1 g for subjects \> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \[DMARDs\], or combination) throughout the double-blind treatment period. | None | None | 124 | 959 | 715 | 959 | View |
| Placebo (PLA) | Participants received Placebo (dextrose 5% water \[D5W\] for injection U.S.P or normal saline \[NS\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \[DMARDs\], or combination) throughout the double-blind treatment period. | None | None | 59 | 482 | 346 | 482 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| HIV TEST POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| PTERYGIUM | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| SCLEROMALACIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| HAEMATOCRIT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| BLOOD GLUCOSE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| TRANSAMINASES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| ELECTROCARDIOGRAM CHANGE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| HEPATIC ENZYME INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| ELECTROCARDIOGRAM ST-T SEGMENT ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| ARRHYTHMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| PERICARDITIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ATRIAL FLUTTER | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CARDIOMYOPATHY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ANGINA PECTORIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ANGINA UNSTABLE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CARDIAC TAMPONADE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CARDIOGENIC SHOCK | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| SICK SINUS SYNDROME | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| AORTIC VALVE DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| MYOCARDIAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| MITRAL VALVE STENOSIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ACUTE CORONARY SYNDROME | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CORONARY ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| HEART VALVE INCOMPETENCE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ISCHAEMIC CARDIOMYOPATHY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CONGESTIVE CARDIOMYOPATHY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CORONARY ARTERY OCCLUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| MITRAL VALVE INCOMPETENCE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| HYPERTENSIVE HEART DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ATRIOVENTRICULAR BLOCK COMPLETE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| ARTERIOSCLEROSIS CORONARY ARTERY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| AORTIC ANEURYSM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| AORTIC STENOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| ARTERIOSCLEROSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| AORTIC DISSECTION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| ARTERIAL STENOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| VENOUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| EXTREMITY NECROSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| VASCULAR OCCLUSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| HYPERTENSIVE CRISIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| ILIAC ARTERY EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| RHEUMATOID VASCULITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| VENOUS THROMBOSIS LIMB | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| AXILLARY VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| PERIPHERAL VASCULAR DISORDER | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| THROMBOPHLEBITIS SUPERFICIAL | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| HYPERTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 12.1 | View |
| VICTIM OF HOMICIDE | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 12.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| SUICIDE ATTEMPT | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| BIPOLAR DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| MAJOR DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| MENTAL STATUS CHANGES | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| HEPATITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| CHOLANGITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| HEPATIC MASS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| LIVER INJURY | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| BILIARY COLIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| CHOLECYSTITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| ANAPHYLACTIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 12.1 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| SCIATICA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| PRESYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| RADICULOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| ENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| POLYNEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| ISCHAEMIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| MOYAMOYA DISEASE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| NERVE COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| CEREBRAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| CERVICAL MYELOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| SPINAL CLAUDICATION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| CEREBRAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| LOSS OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| CARPAL TUNNEL SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| NERVE ROOT COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| CAROTID ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| CEREBROVASCULAR DISORDER | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| SUBARACHNOID HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| RUPTURED CEREBRAL ANEURYSM | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| COMPLEX REGIONAL PAIN SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| FAECALOMA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| GINGIVITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ANAL FISSURE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| DIVERTICULUM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| OESOPHAGITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| COLONIC ATONY | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| GASTRIC ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| UMBILICAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| COLITIS ISCHAEMIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| GASTRITIS EROSIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| OESOPHAGEAL SPASM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| OESOPHAGEAL ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| PANCREATITIS ACUTE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| INTESTINAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| DIVERTICULAR PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| IRRITABLE BOWEL SYNDROME | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| MESENTERIC ARTERY EMBOLISM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| LARGE INTESTINE PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL HERNIA OBSTRUCTIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| LOWER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| UPPER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| SUDDEN HEARING LOSS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 12.1 | View |
| DEAFNESS NEUROSENSORY | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 12.1 | View |
| NEUROSENSORY HYPOACUSIS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 12.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| EMPYEMA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| CERVICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| HEPATITIS E | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| ABSCESS LIMB | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BONE ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| EPIGLOTTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| OTITIS MEDIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| ASPERGILLOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| OSTEOMYELITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| TOOTH ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BRONCHIECTASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| HERPES SIMPLEX | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| LUNG INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PYELONEPHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| LOBAR PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BRONCHOPNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| SYSTEMIC MYCOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BONE TUBERCULOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| CANDIDA PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| CHRONIC SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BURSITIS INFECTIVE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| ESCHERICHIA SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| HUMAN EHRLICHIOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PERIRECTAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| ARTHRITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BACTERIAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| HAEMATOMA INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| INFECTED SKIN ULCER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| LOCALISED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| DIARRHOEA INFECTIOUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PYELONEPHRITIS ACUTE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| SUBCUTANEOUS ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| OSTEOMYELITIS CHRONIC | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PERITONSILLAR ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PNEUMONIA HAEMOPHILUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PNEUMONIA PNEUMOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| RESPIRATORY MONILIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| LYMPH NODE TUBERCULOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PNEUMONIA STREPTOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| DEVICE RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| INCISION SITE CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| CELLULITIS STAPHYLOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| POST PROCEDURAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| STREPTOCOCCAL BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| GASTROENTERITIS SALMONELLA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| GASTROINTESTINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| STAPHYLOCOCCAL BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PELVIC INFLAMMATORY DISEASE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| STAPHYLOCOCCAL OSTEOMYELITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| CLOSTRIDIUM DIFFICILE COLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| POSTOPERATIVE WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BRONCHOPULMONARY ASPERGILLOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PNEUMOCYSTIS JIROVECI PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| RENAL INFARCT | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| CALCULUS URETERIC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| RENAL AMYLOIDOSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| GLOMERULONEPHRITIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| STRESS URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| OBESITY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| DIABETES MELLITUS INADEQUATE CONTROL | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| LYMPHADENITIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| BONE MARROW FAILURE | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| BONE MARROW TOXICITY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| SKIN ULCER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| PANNICULITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| SKIN FISSURES | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| DECUBITUS ULCER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| LICHENOID KERATOSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| PYODERMA GANGRENOSUM | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| DERMATITIS PSORIASIFORM | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| CYSTOCELE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| ADENOMYOSIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| METRORRHAGIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| OVARIAN CYST | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| ENDOMETRIOSIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| GYNAECOMASTIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| CERVICAL POLYP | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| BREAST DISORDER | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| MENOMETRORRHAGIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| UTERINE PROLAPSE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| UTERINE HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| VAGINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| FIBROCYSTIC BREAST DISEASE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| BENIGN PROSTATIC HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| CONGENITAL CEREBRAL CYST | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 12.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| POISONING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| UNDERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| LIMB INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| RIB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| FOOT FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| ANKLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| DEVICE FAILURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| TENDON RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| WRIST FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| FIBULA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| PELVIC FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| SKIN LACERATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| STRESS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| FOREARM FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| MEDICATION ERROR | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| WOUND DEHISCENCE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| CLAVICLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| JOINT DISLOCATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| BURNS THIRD DEGREE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| DEVICE DISLOCATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| LOWER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| PUBIC RAMI FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| UPPER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| LIMB CRUSHING INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| FACIAL BONES FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| TRAUMATIC LIVER INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| DISLOCATION OF VERTEBRA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| DRUG ADMINISTRATION ERROR | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| THERAPEUTIC AGENT TOXICITY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| INCORRECT DOSE ADMINISTERED | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| MEDICAL DEVICE COMPLICATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| SPINAL COMPRESSION FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| SUTURE RELATED COMPLICATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| POST PROCEDURAL COMPLICATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| DISLOCATION OF JOINT PROSTHESIS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.1 | View |
| ABORTION SPONTANEOUS | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | View |
| BURSITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| SYNOVITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| ARTHROPATHY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| BONE EROSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| OSTEOPOROSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| OSTEONECROSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| FOOT DEFORMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| HAND DEFORMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| COSTOCHONDRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| JOINT ANKYLOSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| FINGER DEFORMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| JOINT DESTRUCTION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| RHEUMATOID NODULE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| RHEUMATOID ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| OSTEOPOROTIC FRACTURE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| SPINAL OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| LUMBAR SPINAL STENOSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| MUSCULOSKELETAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| INTERVERTEBRAL DISC DISORDER | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| INTERVERTEBRAL DISC DEGENERATION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| BRONCHOSPASM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| LUNG DISORDER | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| PLEURITIC PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| BRONCHIAL POLYP | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| RHEUMATOID LUNG | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| TRACHEAL STENOSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| BRONCHITIS CHRONIC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| PULMONARY FIBROSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| STATUS ASTHMATICUS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| SLEEP APNOEA SYNDROME | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| NASAL SEPTUM DEVIATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| HERNIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| HYPERTHERMIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| IMPAIRED HEALING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| HERNIA OBSTRUCTIVE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| LIPOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| OSTEOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| LEIOMYOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| BREAST CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| COLON ADENOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| LUNG NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| ADENOMA BENIGN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| GASTRIC CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| LEIOMYOSARCOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| THYROID CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| BOWEN'S DISEASE | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| KAPOSI'S SARCOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| UTERINE LEIOMYOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| ENDOMETRIAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| MALIGNANT MELANOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| LUNG ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| SEBACEOUS CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| PANCREATIC CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| RENAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| BREAST CANCER IN SITU | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| LUNG CANCER METASTATIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| NON-HODGKIN'S LYMPHOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| LUNG NEOPLASM MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| PITUITARY TUMOUR BENIGN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| SQUAMOUS CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| MYELODYSPLASTIC SYNDROME | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| CERVIX CARCINOMA STAGE II | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| MALIGNANT MELANOMA IN SITU | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| NON-SMALL CELL LUNG CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| SQUAMOUS CELL CARCINOMA OF SKIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| SQUAMOUS CELL CARCINOMA OF THE CERVIX | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| SMALL CELL LUNG CANCER STAGE UNSPECIFIED | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| CONJUNCTIVITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| RHINITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |