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Visit 9 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulier, 19 Itemgroepen, 65 Data-elementen, 1 Taal
Itemgroepen: 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 8 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulier, 14 Itemgroepen, 54 Data-elementen, 1 Taal
Itemgroepen: 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 10 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulier, 13 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: 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 Formulier, 13 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: 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 Formulier, 16 Itemgroepen, 38 Data-elementen, 1 Taal
Itemgroepen: 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

Visit 14 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulier, 12 Itemgroepen, 30 Data-elementen, 1 Taal
Itemgroepen: 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, Additional Observations, Vital Signs 2, Secondary Endpoint Criteria, 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 14

Study Completion Study Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulier, 3 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Additional Observations, Study Completion, Casebook Signature
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 Study Completion

Concomitant Medications Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulier, 3 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Additional Observations, Prior/Concomitant Medications, application of medication
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 Concomitant Medications

System Screening Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulier, 1 Itemgroep, 3 Data-elementen, 1 Taal
Itemgroep: System Screening
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 System Screening

Visit 13 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulier, 17 Itemgroepen, 44 Data-elementen, 1 Taal
Itemgroepen: 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, 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 13

Visit 12 Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulier, 17 Itemgroepen, 58 Data-elementen, 1 Taal
Itemgroepen: 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, Echocardiography, SF-36 Health Survey, Modified Brief Pain Inventory, Secondary Endpoint Criteria, 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 12

Adverse Events Galafold (migalastat) AT1001-012 NCT01218659

- 11-11-16 - 1 Formulier, 2 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Additional Observations, Adverse Events
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 Adverse Events

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