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  1. 1. Clinical Trial
  2. 2. Routine Documentation
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  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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Visit 9 Galafold (migalastat) AT1001-012 NCT01218659

- 11/11/16 - 1 form, 19 itemgroups, 65 items, 1 language
Itemgroups: 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 form, 19 itemgroups, 65 items, 1 language
Itemgroups: 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 form, 19 itemgroups, 65 items, 1 language
Itemgroups: 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 form, 14 itemgroups, 54 items, 1 language
Itemgroups: 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 form, 14 itemgroups, 54 items, 1 language
Itemgroups: 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 form, 14 itemgroups, 54 items, 1 language
Itemgroups: 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 form, 14 itemgroups, 54 items, 1 language
Itemgroups: 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 form, 13 itemgroups, 48 items, 1 language
Itemgroups: 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 form, 13 itemgroups, 48 items, 1 language
Itemgroups: 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 form, 16 itemgroups, 38 items, 1 language
Itemgroups: 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 form, 12 itemgroups, 30 items, 1 language
Itemgroups: 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

Visit 13 Galafold (migalastat) AT1001-012 NCT01218659

- 11/11/16 - 1 form, 17 itemgroups, 44 items, 1 language
Itemgroups: 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

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