ID

18589

Descripción

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 Follow-up

Palabras clave

Versiones (2)
  1. 2/11/16 2/11/16 -
  2. 11/11/16 11/11/16 -
Subido en

11 de noviembre de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Follow-up Galafold (migalastat) AT1001-012 NCT01218659

Inglés

Follow-up Galafold (migalastat) AT1001-012 NCT01218659

1 formularios  
Date of visit
Descripción

Date of visit

Alias
UMLS CUI-1
C1320303
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
12 Lead ECG
Descripción

12 Lead ECG

Alias
UMLS CUI-1
C1623258
Date ECG was performed
Descripción

ECG Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
ECG results
Descripción

ECG results

Tipo de datos

integer

Alias
UMLS CUI [1]
C1623258
Hematology/Coagulation
Descripción

Hematology/Coagulation

Alias
UMLS CUI-1
C0474523
Hematology Sample Collection Date
Descripción

Hematology Sample Collection Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0011008
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
Descripción

Hematology finding; Laboratory test finding

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0587081
Hematology: clinically significant abnormal laboratory values, please sepcify
Descripción

Hematology: clinically significant abnormal laboratory values, please sepcify

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C1853129
UMLS CUI-3
C2826293
Hematology: clinically significant abnormal laboratory values, please sepcify
Descripción

If lab abnormalities=Yes

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1853129
UMLS CUI [1,3]
C2826293
Chemistry, Laboratory findings
Descripción

Chemistry, Laboratory findings

Alias
UMLS CUI-1
C0007996
UMLS CUI-2
C0022885
Chemistry Sample Collection Date
Descripción

Chemistry Sample Collection Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0007996
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0011008
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
Descripción

Science of Chemistry; Laboratory test finding

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0007996
UMLS CUI [1,2]
C0587081
Chemistry: clinically significant abnormal laboratory values, please specify
Descripción

Chemistry: clinically significant abnormal laboratory values, please specify

Alias
UMLS CUI-1
C0005774
UMLS CUI-2
C2826293
Chemistry: clinically significant abnormal laboratory values, please specify
Descripción

If lab abnormalities=Yes

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C2826293
Urinanalysis
Descripción

Urinanalysis

Alias
UMLS CUI-1
C0042014
Urinalysis Sample Collection Date
Descripción

Urinalysis Sample Collection Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0011008
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
Descripción

Urinalysis; Laboratory test finding

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0587081
Urinalysis: clinically significant abnormal laboratory values
Descripción

Urinalysis: clinically significant abnormal laboratory values

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C1853129
UMLS CUI-3
C2826293
Urinalysis: clinically significant abnormal laboratory values
Descripción

If lab abnormalities=Yes

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1853129
UMLS CUI [1,3]
C2826293
Additional Observations
Descripción

Additional Observations

Alias
UMLS CUI-1
C0700325
Reference date
Descripción

reference date

Tipo de datos

date

Alias
UMLS CUI [1]
C1719096
Visit Type
Descripción

Visit

Tipo de datos

text

Alias
UMLS CUI [1]
C0545082
electronic case report form
Descripción

eCRF

Tipo de datos

text

Alias
UMLS CUI [1]
C1516308
Comment
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Date of Assessment
Descripción

Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Body weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure measurement
Descripción

Blood pressure

Tipo de datos

text

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Blood pressure measurement diastolic
Descripción

Blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiration rate, Breathing rate (BR)
Descripción

Respiration Rate

Tipo de datos

integer

Unidades de medida
  • /min
Alias
UMLS CUI [1]
C0231832
/min
Secondary Endpoint Criteria
Descripción

Secondary Endpoint Criteria

Since the last visit, did the subject have a cardiac event that meets the secondary endpoint criteria?
Descripción

cardiovascular event

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320716
Was the subject sent for a cardiac consult?
Descripción

cardiac consult

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0009818
UMLS CUI [1,2]
C0007226
Since the last visit, did the subject have a cerebrovascular event that meets the secondary endpoint criteria?
Descripción

cerebrovascular event

Tipo de datos

integer

Alias
UMLS CUI [1]
C0038454
Was the subject sent for a neurological consult?
Descripción

neurological consult

Tipo de datos

integer

Alias
UMLS CUI [1]
C0849229
Physical Examination
Descripción

Physical Examination

Alias
UMLS CUI-1
C0031809
Date Physical Examination performed:
Descripción

Date of Examination

Tipo de datos

date

Alias
UMLS CUI [1]
C2826643
Physical Exam Status
Descripción

Physical Exam Status

Tipo de datos

integer

Alias
UMLS CUI [1]
C0031809
Physical Exam Findings, Body Systems
Descripción

If Clinically significant findings, please specify

Tipo de datos

integer

Alias
UMLS CUI [1]
C0031809
Physical Exam Findings
Descripción

If Clinically significant findings, please specify

Tipo de datos

text

Alias
UMLS CUI [1]
C0031809
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Similar models

Follow-up Galafold (migalastat) AT1001-012 NCT01218659

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Date of visit
C1320303 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
12 Lead ECG
C1623258 (UMLS CUI-1)
ECG Date
Item
Date ECG was performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
ECG results
integer
C1623258 (UMLS CUI [1])
ECG results
Code List
ECG results
CL Item
Normal (1)
CL Item
Abnormal, not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
Item Group
C0474523 (UMLS CUI-1)
Hematology Sample Collection Date
Item
Hematology Sample Collection Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
integer
C0474523 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Hematology finding; Laboratory test finding
Code List
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Hematology: clinically significant abnormal laboratory values, please sepcify
C0474523 (UMLS CUI-1)
C1853129 (UMLS CUI-2)
C2826293 (UMLS CUI-3)
Item
Hematology: clinically significant abnormal laboratory values, please sepcify
integer
C0474523 (UMLS CUI [1,1])
C1853129 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
clinically significant abnormal laboratory values Hematology
Code List
Hematology: clinically significant abnormal laboratory values, please sepcify
CL Item
Total Hemoglobin (1)
CL Item
Hematocrit (2)
CL Item
Erythrocyte (3)
CL Item
Platelet Count (4)
CL Item
Leukocyte (5)
CL Item
MCV (6)
CL Item
MCH (7)
CL Item
MCHC (8)
CL Item
RDW (9)
CL Item
Neutrophils (10)
CL Item
Lymphocytes (11)
CL Item
Monocytes (12)
CL Item
Eosinophils (13)
CL Item
Basophils (14)
CL Item
Neutrophils, ABS (15)
CL Item
Lymphocytes, ABS (16)
CL Item
Monocytes, ABS (17)
CL Item
Eosinophils, ABS (18)
CL Item
Basophils, ABS (19)
CL Item
Morphology (20)
CL Item
Co-Ag, INR (Screening only) (21)
CL Item
Co-Ag, aPTT (Screening only) (22)
Item Group
Chemistry, Laboratory findings
C0007996 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Chemistry Sample Collection Date
Item
Chemistry Sample Collection Date
date
C0007996 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
integer
C0007996 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Science of Chemistry; Laboratory test finding
Code List
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Chemistry: clinically significant abnormal laboratory values, please specify
C0005774 (UMLS CUI-1)
C2826293 (UMLS CUI-2)
Item
Chemistry: clinically significant abnormal laboratory values, please specify
integer
C0005774 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
clinically significant abnormal laboratory values Chemistry
Code List
Chemistry: clinically significant abnormal laboratory values, please specify
CL Item
AST (1)
CL Item
ALT (2)
CL Item
Alkaline Phosphate (3)
CL Item
Total Bilirubin (4)
CL Item
Creatinine (5)
CL Item
Urea (6)
CL Item
Non-Fasting Glucose (7)
CL Item
Calcium (8)
CL Item
Calcium (Albumin Corrected) (9)
CL Item
Sodium (10)
CL Item
Potassium (11)
CL Item
Magnesium (12)
CL Item
Total Protein (13)
CL Item
Albumin (14)
CL Item
Bicarbonate (15)
CL Item
LDH (16)
CL Item
Blood Urea Nitrogen (BUN) (17)
CL Item
Chloride (18)
CL Item
Phosphorus (19)
CL Item
eGFR MDRD, ID MS Traceable (20)
CL Item
Cholesterol  (21)
CL Item
Creatinine Phosphokinase (CPK) (22)
CL Item
Glutamyltransferase (23)
CL Item
Triglyceride (24)
CL Item
Uric Acid (25)
Item Group
C0042014 (UMLS CUI-1)
Urinalysis Sample Collection Date
Item
Urinalysis Sample Collection Date
date
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
integer
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Urinalysis; Laboratory test finding
Code List
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Urinalysis: clinically significant abnormal laboratory values
C0042014 (UMLS CUI-1)
C1853129 (UMLS CUI-2)
C2826293 (UMLS CUI-3)
Item
Urinalysis: clinically significant abnormal laboratory values
integer
C0042014 (UMLS CUI [1,1])
C1853129 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
clinically significant abnormal laboratory values Urinalysis
Code List
Urinalysis: clinically significant abnormal laboratory values
CL Item
Specific Gravity (1)
CL Item
pH (2)
CL Item
Protein (3)
CL Item
Glucose (4)
CL Item
Ketones (5)
CL Item
Blood (6)
CL Item
Leukocyte Esterase (7)
CL Item
Nitrite (8)
CL Item
Bilirubin (9)
CL Item
Urobilinogen (10)
CL Item
WBC (11)
CL Item
RBC (12)
CL Item
Color (13)
CL Item
Apperance (14)
CL Item
Microalbumin, 24-HR Urine (mg/day) (15)
CL Item
Protein, 24-HR Urine (mg/day) (16)
CL Item
Microscopic (17)
CL Item
WBC Casts (18)
CL Item
Epithelial Cells (19)
CL Item
Renal Tubular Cells (20)
CL Item
Transitional Epithelial Cells (21)
CL Item
Bacterial Casts (22)
CL Item
Epithelial Casts (23)
CL Item
Fatty Casts (24)
CL Item
Granular Casts (25)
CL Item
Hyaline Casts (26)
CL Item
Mixed Casts (27)
CL Item
RBC Casts (28)
CL Item
Waxy Casts (29)
CL Item
Amorphous Urate Crystals (30)
CL Item
Acid Urate Crystals (31)
CL Item
Ammonium Biurate Crystals (32)
CL Item
Amorphous Crystals (33)
CL Item
Ammonium Oxalate Crystals (34)
CL Item
Ammonium Phosphate Crystals (35)
CL Item
Bilirubin Crystals (36)
CL Item
Calcium Oxalate Crystals (37)
CL Item
Calcium Phospate Crystals (38)
CL Item
Calcium Carbonate Crystals (39)
CL Item
Cystine Crystals (40)
CL Item
Cholesterol Crystals (41)
CL Item
Hippuric Acid Crystals (42)
CL Item
Leucine Crystals (43)
CL Item
Monosodium Urate Crystals (44)
CL Item
Sulfa Crystals (45)
CL Item
Triple Phosphate Crystals (46)
CL Item
Tyrosine Crystals (47)
CL Item
Uric Acid Crystals (48)
CL Item
Bacteria (49)
CL Item
Fat Bodies (50)
CL Item
Starch Granules (51)
CL Item
Trichomonas (52)
CL Item
Yeast (53)
CL Item
Microalbumin, Urine Conc (54)
CL Item
Creatinine, Urine 24-Hr (55)
CL Item
Creatinine, Urine Conc (56)
CL Item
Protein, Urine 24-Hr (57)
CL Item
Urine total protein, random (58)
Item Group
C0700325 (UMLS CUI-1)
reference date
Item
Reference date
date
C1719096 (UMLS CUI [1])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
eCRF
Item
electronic case report form
text
C1516308 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Assessment Date
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Blood pressure
Item
Blood pressure measurement
text
C0005823 (UMLS CUI [1])
Blood pressure
Item
Blood pressure measurement diastolic
integer
C0005823 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiration Rate
Item
Respiration rate, Breathing rate (BR)
integer
C0231832 (UMLS CUI [1])
Item
Since the last visit, did the subject have a cardiac event that meets the secondary endpoint criteria?
integer
C1320716 (UMLS CUI [1])
undefined item
Code List
Since the last visit, did the subject have a cardiac event that meets the secondary endpoint criteria?
CL Item
Yes (1)
CL Item
No (2)
Item
Was the subject sent for a cardiac consult?
integer
C0009818 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
cardiac consult
Code List
Was the subject sent for a cardiac consult?
CL Item
Yes (1)
CL Item
No (2)
Item
Since the last visit, did the subject have a cerebrovascular event that meets the secondary endpoint criteria?
integer
C0038454 (UMLS CUI [1])
undefined item
Code List
Since the last visit, did the subject have a cerebrovascular event that meets the secondary endpoint criteria?
CL Item
Yes (1)
CL Item
No (2)
Item
Was the subject sent for a neurological consult?
integer
C0849229 (UMLS CUI [1])
neurological consult
Code List
Was the subject sent for a neurological consult?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Date of Examination
Item
Date Physical Examination performed:
date
C2826643 (UMLS CUI [1])
Item
Physical Exam Status
integer
C0031809 (UMLS CUI [1])
Physical Exam Status
Code List
Physical Exam Status
CL Item
No clinically significant findings since previous Physical Examination (1)
CL Item
Clinically significant findings (2)
CL Item
Not done (3)
Item
Physical Exam Findings, Body Systems
integer
C0031809 (UMLS CUI [1])
Body Systems Physical Exam Findings
Code List
Physical Exam Findings, Body Systems
CL Item
Head/Eyes/Ears/Nose/Throat (1)
CL Item
Respiratory (2)
CL Item
Cardiovascular (3)
CL Item
Dermatological (4)
CL Item
Lymphatics/Lymph nodes (5)
CL Item
Gastrointestinal (6)
CL Item
Neurological (7)
CL Item
Genitourinary (8)
CL Item
Musculoskeletal (9)
CL Item
General (10)
Physical Exam Findings
Item
Physical Exam Findings
text
C0031809 (UMLS CUI [1])
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