Adverse Events Module

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 @ 1:40 AM
Ignite Modification Date: 2025-12-25 @ 11:56 PM
NCT ID: NCT02367794
Description: All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received at least one dose of any study medication.
Frequency Threshold: 5
Time Frame: From the first study drug administration to the data cutoff date: 17 February 2021 (up to approximately 68 months).
Study: NCT02367794
Study Brief: A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
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 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
Serious Events(If Any):

Serious Events

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
Other Events(If Any):

Other Events

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