Adverse Events Module

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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 @ 5:59 PM
Ignite Modification Date: 2025-12-25 @ 3:21 PM
NCT ID: NCT01332968
Description: The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.
Frequency Threshold: 5
Time Frame: Baseline up to 10 years
Study: NCT01332968
Study Brief: A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rituximab+Chemotherapy Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. 111 None 309 692 675 692 View
Obinutuzumab+Chemotherapy Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. 104 None 361 698 690 698 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
OBSTRUCTIVE PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
INFUSION SITE EXTRAVASATION 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
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
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
HYPOGAMMAGLOBULINAEMIA SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
ABDOMINAL SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ABSCESS INTESTINAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ARTHRITIS BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ARTHRITIS INFECTIVE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ATYPICAL PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ENTEROCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
EPIGLOTTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ESCHERICHIA INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ESCHERICHIA URINARY TRACT INFECTION 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
WHITE BLOOD CELLS URINE POSITIVE SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
FLUID OVERLOAD SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPERCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
SPINAL STENOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
SYNOVITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
TEMPOROMANDIBULAR JOINT SYNDROME SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
ACOUSTIC NEUROMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
GASTRIC CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
GASTROINTESTINAL NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
HEPATIC CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
HODGKIN'S DISEASE SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
HODGKIN'S DISEASE NODULAR SCLEROSIS SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
HODGKIN'S DISEASE STAGE II SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
HORMONE RECEPTOR POSITIVE BREAST CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
INTRADUCTAL PROLIFERATIVE BREAST LESION SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
INTRAOCULAR MELANOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
INVASIVE DUCTAL BREAST CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
KERATOACANTHOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
RENAL CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
RENAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
SCHWANNOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
SQUAMOUS CELL BREAST CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
SQUAMOUS CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
SQUAMOUS CELL CARCINOMA OF SKIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
THYROID ADENOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
IMMUNE THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
MYELOSUPPRESSION SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
SPLENOMEGALY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
ANGINA PECTORIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
AORTIC VALVE STENOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
CARDIO-RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
CARDIOGENIC SHOCK SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
CORONARY ARTERY STENOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
MYOCARDIAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
RIGHT VENTRICULAR FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
SINUS BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
SINUS TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
SUPRAVENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
VENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
HEREDITARY MOTOR AND SENSORY NEUROPATHY SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 24.0 View
DEAFNESS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
CORNEAL OPACITY SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
ASCITES 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
CROHN'S DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
ENTEROVESICAL FISTULA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
FAECALOMA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
GASTRIC HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
GASTRIC ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
GASTRITIS EROSIVE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
GASTROENTERITIS EOSINOPHILIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
HAEMATEMESIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
HAEMORRHOIDS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
HIATUS HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
ILEUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
INGUINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
INTESTINAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
INTESTINAL POLYP SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
INTESTINAL VILLI ATROPHY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
LARGE INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
LARGE INTESTINE POLYP SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
MELAENA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
MIKULICZ'S SYNDROME SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
MOUTH ULCERATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
PANCREATITIS ACUTE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
RECTAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
SUBACUTE PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
SWOLLEN TONGUE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
UMBILICAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
UPPER GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
ADVERSE DRUG REACTION 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
CYST RUPTURE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
GENERAL PHYSICAL HEALTH DETERIORATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
HYPERPLASIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
HYPERTHERMIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
ILL-DEFINED DISORDER SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
STENT-GRAFT ENDOLEAK SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
SWELLING FACE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
BILE DUCT STENOSIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
BILE DUCT STONE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
BILIARY COLIC SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
CHOLANGITIS 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
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
DRUG-INDUCED LIVER INJURY SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
HEPATIC CIRRHOSIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
HEPATIC FUNCTION ABNORMAL SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
HEPATITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
HEPATITIS ACUTE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
ALLERGY TO ARTHROPOD BITE SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
ANAPHYLACTIC REACTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
ANAPHYLACTIC SHOCK SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
CYTOKINE RELEASE SYNDROME SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
DRUG HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
BACTERIAL TRACHEITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
BK VIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
BREAST ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CAMPYLOBACTER INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CATHETER SITE CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CHRONIC SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CLOSTRIDIUM DIFFICILE COLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COMPLICATED APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CYTOMEGALOVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
DEVICE RELATED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
DEVICE RELATED SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
DIVERTICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ENCEPHALITIS ENTEROVIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ENDOCARDITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
FEBRILE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
GASTROENTERITIS ESCHERICHIA COLI SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
HERPES ZOSTER INFECTION NEUROLOGICAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
HERPES ZOSTER OTICUS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
INFECTED CYST SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
INTERVERTEBRAL DISCITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
MASTOIDITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
MENINGITIS ENTEROVIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
MUCOSAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
NEUROBORRELIOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
NEUTROPENIC INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
NEUTROPENIC SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
OESOPHAGEAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
OESOPHAGEAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
OOPHORITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ORAL HERPES SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
OTITIS MEDIA CHRONIC SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
OVARIAN BACTERIAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PARAPHARYNGEAL SPACE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PELVIC ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PERIODONTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PERITONSILLAR ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PNEUMOCYSTIS JIROVECII 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 BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PNEUMONIA FUNGAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PNEUMONIA PNEUMOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
POST PROCEDURAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PULMONARY SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PYELONEPHRITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Q FEVER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
RHINOVIRUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
SCROTAL ABSCESS 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
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
SINUSITIS BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
SINUSITIS FUNGAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
SOFT TISSUE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
STAPHYLOCOCCAL BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
STAPHYLOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
SUBCUTANEOUS ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
TUBERCULOSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
TUBO-OVARIAN ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
VARICELLA ZOSTER SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
VASCULAR DEVICE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
VIRAL MYOSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ACCIDENT SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
ALCOHOL POISONING SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
ANASTOMOTIC STENOSIS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
ANKLE FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
BRAIN CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
CARTILAGE INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
COMPRESSION FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
FACIAL BONES FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
FEMUR FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
FOOT FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
HAND FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
HUMERUS FRACTURE 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
LIGAMENT SPRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
LUMBAR VERTEBRAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
MEDICATION ERROR SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
MENISCUS INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
MULTIPLE FRACTURES SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
PNEUMOTHORAX TRAUMATIC SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
POST PROCEDURAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
SEROMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
SPINAL COMPRESSION FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
THORACIC VERTEBRAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
UPPER LIMB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 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 CREATININE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
HEPATIC ENZYME INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
INTERNATIONAL NORMALISED RATIO INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
RESPIROVIRUS TEST POSITIVE SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
TUMOUR LYSIS SYNDROME SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
ARTHROPATHY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
FLANK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
HAEMARTHROSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
MYOPATHY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
MYOSITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
OSTEITIS DEFORMANS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
OSTEOARTHRITIS 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
PATHOLOGICAL FRACTURE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
ROTATOR CUFF SYNDROME SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
SERONEGATIVE ARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
SPINAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
ACUTE LYMPHOCYTIC LEUKAEMIA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
ACUTE MYELOID LEUKAEMIA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
ADENOCARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
ADENOCARCINOMA METASTATIC SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
ADENOCARCINOMA OF COLON SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
BASAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
BENIGN LARYNGEAL NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
BLADDER TRANSITIONAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
BLADDER TRANSITIONAL CELL CARCINOMA METASTATIC SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
BOWEN'S DISEASE SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
BREAST CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
CANCER PAIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
CHOLANGIOCARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
COLON CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
COLORECTAL CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
DUCTAL ADENOCARCINOMA OF PANCREAS SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
GASTRIC ADENOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
LARYNGEAL SQUAMOUS CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
LENTIGO MALIGNA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
LUNG ADENOCARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
LUNG NEOPLASM MALIGNANT SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
MALIGNANT MELANOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
MENINGIOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
MYELODYSPLASTIC SYNDROME SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
NEUROENDOCRINE CARCINOMA OF THE SKIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
NON-HODGKIN'S LYMPHOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
NON-SMALL CELL LUNG CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
NON-SMALL CELL LUNG CANCER STAGE IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
OESOPHAGEAL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
PANCREATIC CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
PAPILLARY THYROID CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
PITUITARY TUMOUR BENIGN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
PROSTATE CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
RECTAL ADENOCARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
TRANSITIONAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
TUMOUR FLARE SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
UTERINE CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
VULVOVAGINAL WARTS SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
AMYOTROPHIC LATERAL SCLEROSIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
ATAXIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
BRACHIAL PLEXOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
CAROTID ARTERY STENOSIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
CEREBRAL DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
CEREBRAL HAEMATOMA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
CEREBRAL INFARCTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
CEREBRAL ISCHAEMIA 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
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
DIZZINESS POSTURAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
DYSDIADOCHOKINESIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
ENCEPHALOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
EPILEPSY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
FACIAL PARALYSIS 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
HYPERAMMONAEMIC ENCEPHALOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
HYPOTONIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
ISCHAEMIC STROKE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
LOSS OF CONSCIOUSNESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
MONOPARESIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
NERVOUS SYSTEM DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
NEURALGIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
NEUROPATHY PERIPHERAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
ORTHOSTATIC INTOLERANCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
ORTHOSTATIC TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
PARKINSON'S DISEASE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
POLYNEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
SEIZURE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
SPINAL CORD COMPRESSION 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
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
ABORTION SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 24.0 View
DEVICE BREAKAGE SYSTEMATIC_ASSESSMENT Product Issues MedDRA 24.0 View
ALCOHOL PROBLEM SYSTEMATIC_ASSESSMENT Psychiatric 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
EMOTIONAL DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
MENTAL STATUS CHANGES SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
PSYCHOTIC DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
SUBSTANCE-INDUCED PSYCHOTIC DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
SUICIDE ATTEMPT SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
NEPHROLITHIASIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
RENAL COLIC SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
RENAL INFARCT SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
RENAL PAIN SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
RENAL PELVIS FISTULA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
URETERIC OBSTRUCTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
OVARIAN CYST SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
OVARIAN MASS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
PROSTATITIS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
VAGINAL ULCERATION SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
VULVOVAGINAL PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
ACUTE LUNG INJURY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
ACUTE RESPIRATORY DISTRESS SYNDROME SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
ACUTE RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
ASTHMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
BRONCHOSPASM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 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
EMPHYSEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
HYPOXIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
INTERSTITIAL LUNG DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
LUNG CONSOLIDATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
LUNG DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
PARANASAL CYST SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
PHARYNGEAL INFLAMMATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
PHARYNGEAL PARAESTHESIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
PLEURISY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
PLEURITIC PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
PNEUMONIA ASPIRATION 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 ARTERIAL HYPERTENSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
PULMONARY CONGESTION 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 ARREST SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
RESPIRATORY DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
ACTINIC KERATOSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
DERMATITIS CONTACT SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
DERMATITIS EXFOLIATIVE GENERALISED SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
DRUG ERUPTION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
RASH 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
URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
AXILLARY VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
CIRCULATORY COLLAPSE SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
DEEP VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
EMBOLISM SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
HYPERTENSIVE CRISIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
HYPERTENSIVE URGENCY SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
PELVIC VENOUS THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
PERIPHERAL ARTERY ANEURYSM SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
PERIPHERAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
AUTOIMMUNE HAEMOLYTIC ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
DISSEMINATED INTRAVASCULAR COAGULATION SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
GRANULOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
HAEMOLYSIS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
HAEMOLYTIC ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
MUCOSAL INFLAMMATION 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
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
ORAL HERPES SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations 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
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
MYALGIA 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
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
NEUROPATHY PERIPHERAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
PERIPHERAL SENSORY NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric 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
OROPHARYNGEAL 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
THROAT IRRITATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
ALOPECIA 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
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
FLUSHING SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
HOT FLUSH 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
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
ANAEMIA 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
ABDOMINAL PAIN 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
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
STOMATITIS 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
INFUSION RELATED REACTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View