Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 11:15 PM

Ignite Modification Date: 2025-12-25 @ 8:52 PM

NCT ID: NCT00065156

Description: None

Frequency Threshold: 5

Time Frame: Up to 2 years

Study: NCT00065156

Study Brief: Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic Abnormality

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Lenalidomide	The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.	None	None	89	148	148	148	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Femur Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Infection NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Medical Device Complication	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Multi-Organ Failure	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Myocardial Infarction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Pleural Effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonitis NOS	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary Hypertension NOS	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Rash NOS	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rectal Haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Renal Failure NOS	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Transient Ischaemic Attack	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Urinary Tract Infection NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Acute Febrile Neutrophilic Dermatosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Aphasia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Arthrlagia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Asthma NOS	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Azotaemia	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
B-Cell Lymphoma NOS	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Back Pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Blood Creatinine Increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Bronchitis Acute NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Carcinoid Tumour of the Small Bowel	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Cardio-Respiratory Arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiomyopathy NOS	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Central Line Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cerebral Haemorrhage	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Cervical Dysplasia	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Chest Pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Cholecystitis NOS	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Chronic Obstructive Airways Disease Exacerbated	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Clostridial Infection NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Coagulopathy	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Colitis Ischaemic	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Colonic Polyp	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Comminuted Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Convulsions NOS	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dementia NOS	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dermatitis Medicamentosa	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Diastolic Dysfunction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Enterobacter Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Gastritis NOS	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrooesophageal Reflux Disease	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Groin Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Herpes Zoster	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Hiatus Hernia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Hip Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Hyperbilirubinaemia	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Hypernatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypersensitivity NOS	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Hypertensive Encephalopathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hypoglycaemia NOS	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypotension NOS	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Influenza	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Intermittent Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Intestinal Perforation NOS	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Irritable Bowel Syndrome	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Klebsiella Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Lobar Pneumonia NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Localised Osteoarthritis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Lung Cancer Metastatic	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Lung Infiltration NOS	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Migraine NOS	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Multiple Myeloma	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Oesophageal Perforation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Osteolysis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Ovarian Cancer NOS	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Overdose NOS	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Periarthritis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Peripheral Ischaemia	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Perirectal Abscess	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Post Procedural Site Wound Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pulmonary Oedema NOS	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Refractory Anaemia with Excess Blasts in Transformation	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Renal Failure Acute	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Respiratory Distress	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Rigors	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Senile Dementia NOS	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Sinusitis Acute NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sinusitis NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Spinal Compression Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Subarachnoid Haemorrhage NOS	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Subdural Haematoma	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Sudden Death	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Tachyarrhythmia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Thrombophlebitis Superficial	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Thymoma NOS	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Troponin I Increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Vaginosis Fungal NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Vertigo	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Deep Vein Thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Pulmonary Embolism	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Vomiting NOS	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal Pain NOS	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Diarrhoea NOS	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Acute Myeloid Leukaemia NOS	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Atrial Fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Gastroenteritis NOS	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Leukopenia NOS	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pancytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cardiac Failure NOS	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cerebrovascular Accident	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Depressed Level of Consciousness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dyspnoea NOS	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Fall	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Femoral Neck Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Pneumonia Not Otherwise Specified (NOS)	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Anaemia NOS	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Febrile Neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Acute Leukaemia NOS	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Cardiac Failure Congestive	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sepsis NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Anaemia NOS	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Muscle Cramp	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pharyngitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pain in Limb	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Abdominal Pain NOS	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hypokalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Dry Skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Urinary Tract Infection NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Anorexia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Insomnia	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Leukopenia NOS	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Myalgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Sinusitis NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Contusion	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Oedema NOS	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Vomiting NOS	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Bronchitis NOS	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea Exertional	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Night Sweats	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Abdominal Pain Upper	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Acquired Hypothyroidism	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Pain NOS	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Peripheral Swelling	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Fall	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hypertension NOS	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Sweating Increased	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Dry Mouth	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dysuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Erythema	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Loose Stools	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Rhinitis NOS	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Weight Decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Chest Pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hypoaesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Influenza	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Toothache	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Alopecia	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Dysgeusia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Ecchymosis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Pain in Foot	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Palpitations	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Paraesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Peripheral Neuropathy NOS	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Conjunctivitis	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Rigors	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Appetite Decreased NOS	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Flatulence	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Herpes Simplex	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Hypocalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Neck Pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Peripheral Sensory Neuropathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Rhinorrhoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Skin Lesions NOS	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Vision Blurred	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Neutropenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Diarrhoea Not Otherwise Specified (NOS)	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pruritus	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Fatigue	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Rash NOS	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Nasopharyngitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Oedema Peripheral	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Back Pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea NOS	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Upper Respiratory Tract Infection NOS	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Alanine Aminotransferase Increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View