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 @ 3:10 AM
Ignite Modification Date: 2025-12-26 @ 1:49 AM
NCT ID: NCT01078805
Description: Per Protocol, this study only required the collection of serious adverse events (SAEs). SAEs were collected during the entire treatment phase plus 30 days after cessation of Forteo treatment, and if the SAE was deemed related to Forteo treatment during the cessation phase.
Frequency Threshold: 0
Time Frame: None
Study: NCT01078805
Study Brief: Study of FORTEO Use in Subjects in the Community Setting
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FORTEO (Teriparatide)-Treated FORTEO: prescribed in accordance with usual clinical practice for up to 24 months None None 432 4085 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Gastric infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Labyrinthitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Lung infection pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Peritonitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pneumonia haemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pseudomembranous colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Small intestine gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Anaemia postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Brain contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Fractured sacrum SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Ligament injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Patella fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Postoperative ileus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Postoperative thoracic procedure complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Pseudomeningocele SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Pubis fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Soft tissue injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Sternal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Therapeutic agent toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Traumatic brain injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Bone scan abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Light chain analysis increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Haemochromatosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Exostosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Fracture nonunion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Joint instability SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Osteitis deformans SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
B-cell small lymphocytic lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Blast cell crisis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Breast cancer in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Breast cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Breast cancer recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Breast cancer stage II SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Breast cancer stage IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Endometrial cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Hepatic neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Laryngeal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Leiomyosarcoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Lung squamous cell carcinoma stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Metastatic malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Non-Hodgkin's lymphoma stage III SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Non-small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Pancreatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Parathyroid tumour benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Small cell lung cancer stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Thymoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Amyotrophic lateral sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Encephalitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Guillain-Barre syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Hypoxic-ischaemic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Lacunar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Radicular pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Alcohol withdrawal syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Acute prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Pyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal amyloidosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal artery stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Renal failure chronic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Stress urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Adenomyosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Breast mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Cystocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Pelvic prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Postmenopausal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Uterine haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Uterovaginal prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Bronchial disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Bronchiectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Hydrothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Idiopathic pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pulmonary arterial hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pulmonary eosinophilia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Status asthmaticus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Colectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.0 View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.0 View
Medical device removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.0 View
Shoulder arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.0 View
Thyroidectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.0 View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Intermittent claudication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Superior mesenteric artery syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Venous insufficiency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Spleen disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Arteriospasm coronary SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Coronary artery perforation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Hypertensive heart disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 14.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Amaurosis fugax SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Abdominal adhesions SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Acute abdomen SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Colonic polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Duodenal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Femoral hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Femoral hernia, obstructive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastrointestinal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastrointestinal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Intestinal infarction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Intestinal strangulation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Regurgitation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Retroperitoneal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Umbilical hernia, obstructive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Device occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Medical device complication SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Biliary cirrhosis primary SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Biliary dyskinesia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Chronic hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Hepatic congestion SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Acquired immunodeficiency syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Anogenital warts SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Appendicitis perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Bronchitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
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