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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm C: Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care. | 252 | None | 96 | 334 | 315 | 334 | View |
| Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. | 245 | None | 168 | 334 | 325 | 334 | View |
| Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. | 243 | None | 151 | 332 | 315 | 332 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA Version 23.1 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA Version 23.1 | View |
| HAEMOLYSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA Version 23.1 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA Version 23.1 | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA Version 23.1 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA Version 23.1 | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| ANGINA UNSTABLE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| ARRHYTHMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| ATRIAL FLUTTER | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| ATRIAL THROMBOSIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| CARDIAC FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| CARDIAC TAMPONADE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| CARDIO-RESPIRATORY ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| CORONARY ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| LEFT VENTRICULAR DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MeDRA Version 23.1 | View |
| TRACHEO-OESOPHAGEAL FISTULA | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MeDRA Version 23.1 | View |
| ADRENAL INSUFFICIENCY | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MeDRA Version 23.1 | View |
| HYPERTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MeDRA Version 23.1 | View |
| HYPOPITUITARISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MeDRA Version 23.1 | View |
| RETINAL DETACHMENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MeDRA Version 23.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| ANAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| DUODENAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| ENTEROCOLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| GASTRIC ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| GASTROINTESTINAL NECROSIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| GASTROINTESTINAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| GASTROINTESTINAL TOXICITY | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| INTESTINAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| LARGE INTESTINE PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| OESOPHAGITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| PANCREATITIS CHRONIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| RECTAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| UPPER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| GAIT DISTURBANCE | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| PERFORMANCE STATUS DECREASED | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| AUTOIMMUNE HEPATITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA Version 23.1 | View |
| BILE DUCT STONE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA Version 23.1 | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA Version 23.1 | View |
| CHOLECYSTITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA Version 23.1 | View |
| DRUG-INDUCED LIVER INJURY | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA Version 23.1 | View |
| HEPATIC FUNCTION ABNORMAL | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA Version 23.1 | View |
| HEPATITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA Version 23.1 | View |
| HEPATITIS TOXIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA Version 23.1 | View |
| IMMUNE-MEDIATED HEPATITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MeDRA Version 23.1 | View |
| ANAPHYLACTIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | MeDRA Version 23.1 | View |
| DRUG HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MeDRA Version 23.1 | View |
| HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS | SYSTEMATIC_ASSESSMENT | Immune system disorders | MeDRA Version 23.1 | View |
| ABDOMINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| ABDOMINAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| CHRONIC HEPATITIS C | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| CLOSTRIDIUM DIFFICILE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| COLONIC ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| ENDOCARDITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| ENTEROCOLITIS INFECTIOUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| HEPATITIS B | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| INFECTED DERMAL CYST | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| LUNG ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| MENINGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| OSTEOMYELITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| PLEURAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| PNEUMONIA BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| PNEUMONIA HAEMOPHILUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| PNEUMONIA STAPHYLOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| PNEUMONIA STREPTOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| PSEUDOMONAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| PULMONARY SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| STOMATOCOCCAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| URINARY TRACT INFECTION STAPHYLOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| VASCULAR DEVICE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| ALCOHOL POISONING | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| CHEST INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| INFUSION RELATED REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| PERIORBITAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| RADIATION OESOPHAGITIS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| RADIATION PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| RIB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| SKIN LACERATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| THORACIC VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| TOXICITY TO VARIOUS AGENTS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MeDRA Version 23.1 | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| BLOOD LACTIC ACID INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| GENERAL PHYSICAL CONDITION ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| LIVER FUNCTION TEST ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| FAILURE TO THRIVE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPERCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| TYPE 2 DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| OSTEONECROSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| OSTEONECROSIS OF JAW | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| PATHOLOGICAL FRACTURE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| POLYARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| POLYMYOSITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| ADENOCARCINOMA OF COLON | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | View |
| BENIGN SALIVARY GLAND NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | View |
| BLADDER CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | View |
| COLON CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | View |
| GALLBLADDER ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | View |
| INFECTED NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | View |
| MYELODYSPLASTIC SYNDROME | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | View |
| TUMOUR EMBOLISM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | View |
| BRAIN OEDEMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| CEREBRAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| DEPRESSED LEVEL OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| EMBOLIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| EPILEPSY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| GUILLAIN-BARRE SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| HEMIPLEGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| HYPERAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| HYPOTONIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| ISCHAEMIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| MOTOR DYSFUNCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| MYXOEDEMA COMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| SPINAL CORD COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| DEVICE DISLOCATION | SYSTEMATIC_ASSESSMENT | Product Issues | MeDRA Version 23.1 | View |
| COMPLETED SUICIDE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA Version 23.1 | View |
| CONFUSIONAL STATE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA Version 23.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA Version 23.1 | View |
| HALLUCINATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA Version 23.1 | View |
| MENTAL STATUS CHANGES | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA Version 23.1 | View |
| SUICIDAL IDEATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA Version 23.1 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MeDRA Version 23.1 | View |
| HYDRONEPHROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MeDRA Version 23.1 | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MeDRA Version 23.1 | View |
| PROSTATITIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MeDRA Version 23.1 | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| ASPIRATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| ATELECTASIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| BRONCHIAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| DIAPHRAGMATIC PARALYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| DYSPNOEA AT REST | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| EMPHYSEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| IMMUNE-MEDIATED PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| INTERSTITIAL LUNG DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| LARYNGEAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| LUNG CONSOLIDATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| LUNG DISORDER | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| PARANASAL CYST | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| PNEUMONIA ASPIRATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| PNEUMOTHORAX SPONTANEOUS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| DERMATITIS ACNEIFORM | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | View |
| ERYTHEMA MULTIFORME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | View |
| THERAPEUTIC EMBOLISATION | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MeDRA Version 23.1 | View |
| TRANSURETHRAL PROSTATECTOMY | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MeDRA Version 23.1 | View |
| ARTERIAL STENOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| ARTERITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| HAEMODYNAMIC INSTABILITY | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| PERIPHERAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| SUPERIOR VENA CAVA SYNDROME | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA Version 23.1 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA Version 23.1 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA Version 23.1 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MeDRA Version 23.1 | View |
| HYPOTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MeDRA Version 23.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MeDRA Version 23.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MeDRA Version 23.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MeDRA Version 23.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MeDRA Version 23.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA Version 23.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MeDRA Version 23.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MeDRA Version 23.1 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MeDRA Version 23.1 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MeDRA Version 23.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | View |