ID

18596

Beschreibung

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

Stichworte

Versionen (2)
  1. 02.11.16 02.11.16 -
  2. 11.11.16 11.11.16 -
Hochgeladen am

11. November 2016

DOI

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Creative Commons BY-NC 3.0
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Visit 14 Galafold (migalastat) AT1001-012 NCT01218659

Englisch

Visit 14 Galafold (migalastat) AT1001-012 NCT01218659

1 Formulare  
Date of visit
Beschreibung

Date of visit

Alias
UMLS CUI-1
C1320303
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
12 Lead ECG
Beschreibung

12 Lead ECG

Alias
UMLS CUI-1
C1623258
Date ECG was performed
Beschreibung

ECG Date

Datentyp

date

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

ECG results

Datentyp

integer

Alias
UMLS CUI [1]
C1623258
Hematology/Coagulation
Beschreibung

Hematology/Coagulation

Alias
UMLS CUI-1
C0474523
Hematology Sample Collection Date
Beschreibung

Hematology Sample Collection Date

Datentyp

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?
Beschreibung

Hematology finding; Laboratory test finding

Datentyp

integer

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

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
Beschreibung

If lab abnormalities=Yes

Datentyp

integer

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

Chemistry, Laboratory findings

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

Chemistry Sample Collection Date

Datentyp

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?
Beschreibung

Science of Chemistry; Laboratory test finding

Datentyp

integer

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

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
Beschreibung

If lab abnormalities=Yes

Datentyp

integer

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

Urinanalysis

Alias
UMLS CUI-1
C0042014
Urinalysis Sample Collection Date
Beschreibung

Urinalysis Sample Collection Date

Datentyp

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?
Beschreibung

Urinalysis; Laboratory test finding

Datentyp

integer

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

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
Beschreibung

If lab abnormalities=Yes

Datentyp

integer

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

Additional Observations

Alias
UMLS CUI-1
C0700325
Reference date
Beschreibung

reference date

Datentyp

date

Alias
UMLS CUI [1]
C1719096
Visit Type
Beschreibung

Visit

Datentyp

text

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

eCRF

Datentyp

text

Alias
UMLS CUI [1]
C1516308
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Date of Assessment
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Body weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure measurement
Beschreibung

Blood pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Blood pressure measurement diastolic
Beschreibung

Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiration rate, Breathing rate (BR)
Beschreibung

Respiration Rate

Datentyp

integer

Maßeinheiten
  • /min
Alias
UMLS CUI [1]
C0231832
/min
Secondary Endpoint Criteria
Beschreibung

Secondary Endpoint Criteria

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

cardiovascular event

Datentyp

integer

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

cardiac consult

Datentyp

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?
Beschreibung

cerebrovascular event

Datentyp

integer

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

neurological consult

Datentyp

integer

Alias
UMLS CUI [1]
C0849229
Physical Examination
Beschreibung

Physical Examination

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

Date of Examination

Datentyp

date

Alias
UMLS CUI [1]
C2826643
Physical Exam Status
Beschreibung

Physical Exam Status

Datentyp

integer

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

If Clinically significant findings, please specify

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
Physical Exam Findings
Beschreibung

If Clinically significant findings, please specify

Datentyp

text

Alias
UMLS CUI [1]
C0031809
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Ähnliche Modelle

Visit 14 Galafold (migalastat) AT1001-012 NCT01218659

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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