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Visit 1 CRFs Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 15 Groupes Item, 68 Eléments de données, 1 Langue
Groupes Item: Date of visit, Demographics, Inclusion and Exclusion Criteria, medical history, Vital Signs, Physical Examination, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 1

Visit 2 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 19 Groupes Item, 64 Eléments de données, 1 Langue
Groupes Item: Date of visit, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, GFR of Iohexol, Echocardiography, SF-36 Health Survey, Modified Brief Pain Inventory, Randomization, Brain MRI, Secondary Endpoint Criteria, Enzyme Replacement Therapy, Drug log
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 2

Visit 9 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 19 Groupes Item, 65 Eléments de données, 1 Langue
Groupes Item: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, GFR of Iohexol, Echocardiography, SF-36 Health Survey, Modified Brief Pain Inventory, Secondary Endpoint Criteria, Enzyme Replacement Therapy, Drug log, Physical Examination
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 9

Visit 5 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 19 Groupes Item, 65 Eléments de données, 1 Langue
Groupes Item: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, GFR of Iohexol, Echocardiography, SF-36 Health Survey, Modified Brief Pain Inventory, Secondary Endpoint Criteria, Enzyme Replacement Therapy, Drug log, Physical Examination
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 5

Visit 7 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 19 Groupes Item, 65 Eléments de données, 1 Langue
Groupes Item: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, GFR of Iohexol, Echocardiography, SF-36 Health Survey, Modified Brief Pain Inventory, Secondary Endpoint Criteria, Enzyme Replacement Therapy, Drug log, Physical Examination
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 7

Visit 8 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 14 Groupes Item, 54 Eléments de données, 1 Langue
Groupes Item: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, Secondary Endpoint Criteria, Enzyme Replacement Therapy, Drug log
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 8

Visit 6 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 14 Groupes Item, 54 Eléments de données, 1 Langue
Groupes Item: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, Secondary Endpoint Criteria, Enzyme Replacement Therapy, Drug log
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 6

Visit 3 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 14 Groupes Item, 54 Eléments de données, 1 Langue
Groupes Item: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, Secondary Endpoint Criteria, Enzyme Replacement Therapy, Drug log
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 3

Visit 4 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 14 Groupes Item, 54 Eléments de données, 1 Langue
Groupes Item: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, Secondary Endpoint Criteria, Enzyme Replacement Therapy, Drug log
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 4

Visit 10 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 13 Groupes Item, 48 Eléments de données, 1 Langue
Groupes Item: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, Secondary Endpoint Criteria, Drug log
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 10

Visit 11 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 13 Groupes Item, 48 Eléments de données, 1 Langue
Groupes Item: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, Secondary Endpoint Criteria, Drug log
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 11

Unscheduled Visit Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulaire, 16 Groupes Item, 38 Eléments de données, 1 Langue
Groupes Item: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, GFR of Iohexol, Echocardiography, Brain MRI, Physical Examination, Unscheduled Visit
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Unscheduled Visit

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