Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
NCT ID:
NCT02657434
Description:
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
Frequency Threshold:
5
Time Frame:
From the first study drug to the data cutoff date: 13 December 2022 (up to approximately 80 months).
Study:
NCT02657434
Study Brief:
A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed | Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. | 190 | None | 149 | 291 | 275 | 291 | View |
| Arm B (Carboplatin or Cisplatin + Pemetrexed) | Participants received IV infusion of 500 mg/m\^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who do not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. | 189 | None | 91 | 274 | 255 | 274 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| FEBRILE BONE MARROW APLASIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| FEBRILE NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| MYOCARDITIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| STRESS CARDIOMYOPATHY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| SUPRAVENTRICULAR TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| HYPOTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 25.1 | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 25.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| AUTOIMMUNE COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| DIVERTICULUM INTESTINAL HAEMORRHAGIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| ENTEROCOLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| GASTRIC PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| GASTROINTESTINAL DISORDER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| OESOPHAGITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| PROCTITIS ULCERATIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| SMALL INTESTINAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| UPPER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| DISEASE SUSCEPTIBILITY | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| GAIT DISTURBANCE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| GENERAL PHYSICAL HEALTH DETERIORATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| AUTOIMMUNE HEPATITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| CHOLANGITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| DRUG-INDUCED LIVER INJURY | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| HEPATITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| HEPATITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| HEPATOTOXICITY | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| CYTOKINE RELEASE SYNDROME | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 25.1 | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 25.1 | View |
| BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| BRONCHOPULMONARY ASPERGILLOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| CAMPYLOBACTER GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| ENCEPHALITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| ESCHERICHIA URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| H3N2 INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| INFECTIOUS PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| MENINGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| NEUTROPENIC SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| OESOPHAGEAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| PERIPHERAL NERVE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| PULMONARY SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| PYELONEPHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| SOFT TISSUE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| INFUSION RELATED REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| INTENTIONAL OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| SKIN INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| STAB WOUND | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| TOXICITY TO VARIOUS AGENTS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| CREATININE RENAL CLEARANCE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| DIABETES MELLITUS INADEQUATE CONTROL | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| GOUT | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| HYPERCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| FRACTURE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| ADENOCARCINOMA GASTRIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| HISTIOCYTIC NECROTISING LYMPHADENITIS | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| METASTASES TO CENTRAL NERVOUS SYSTEM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| PROSTATE CANCER RECURRENT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| TUMOUR EMBOLISM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| APHASIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| ATAXIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| BRAIN OEDEMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| CAROTID ARTERY OCCLUSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| CAROTID ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| CEREBRAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| DEVICE MALFUNCTION | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA Version 25.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.1 | View |
| CATATONIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.1 | View |
| COMPLETED SUICIDE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.1 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.1 | View |
| CHRONIC KIDNEY DISEASE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.1 | View |
| GLYCOSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.1 | View |
| NEPHRITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.1 | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.1 | View |
| RENAL IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.1 | View |
| TUBULOINTERSTITIAL NEPHRITIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.1 | View |
| BENIGN PROSTATIC HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 25.1 | View |
| ATELECTASIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| BRONCHIAL HYPERREACTIVITY | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| HAEMOPTYSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| INTERSTITIAL LUNG DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| ORGANISING PNEUMONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| PHARYNGEAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| PULMONARY HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | View |
| AORTIC EMBOLUS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
| THROMBOPHLEBITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
| VASCULITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
| MYELOSUPPRESSION | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| BILIARY OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| CONGESTIVE HEPATOPATHY | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| GASTROENTERITIS CLOSTRIDIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| LARYNGOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| PNEUMONIA ASPIRATION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| VASCULAR ACCESS SITE CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.1 | View |
| CHANGE IN SEIZURE PRESENTATION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| CARDIAC FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.1 | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| TRACHEITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| CANCER PAIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | View |
| HYPERVENTILATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| PERIPHERAL ARTERY THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
| PERIPHERAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.1 | View |
| HYPOTHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 25.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.1 | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| MUCOSAL INFLAMMATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| CONJUNCTIVITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.1 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| HICCUPS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| LACRIMATION INCREASED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 25.1 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.1 | View |