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])
CL Item
abnormal, not clinically significant (2)
CL Item
abnormal, clinically significant (3)
PR interval
Item
PR interval
float
C0429087 (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])
Code List
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
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])
Code List
Hematology: clinically significant abnormal laboratory values, please sepcify
CL Item
Total Hemoglobin (1)
CL Item
Platelet Count (4)
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
Co-Ag, INR (Screening only) (21)
CL Item
Co-Ag, aPTT (Screening only) (22)
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])
Code List
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
Item
Chemistry: clinically significant abnormal laboratory values, please specify
integer
C0005774 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Code List
Chemistry: clinically significant abnormal laboratory values, please specify
CL Item
Alkaline Phosphate (3)
CL Item
Total Bilirubin (4)
CL Item
Non-Fasting Glucose (7)
CL Item
Calcium (Albumin Corrected) (9)
CL Item
Total Protein (13)
CL Item
Blood Urea Nitrogen (BUN) (17)
CL Item
eGFR MDRD, ID MS Traceable (20)
CL Item
Creatinine Phosphokinase (CPK) (22)
CL Item
Glutamyltransferase (23)
CL Item
Triglyceride (24)
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])
Code List
Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
Item
Urinalysis: clinically significant abnormal laboratory values, please specify
integer
C0042014 (UMLS CUI [1,1])
C1853129 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Code List
Urinalysis: clinically significant abnormal laboratory values, please specify
CL Item
Specific Gravity (1)
CL Item
Leukocyte Esterase (7)
CL Item
Urobilinogen (10)
CL Item
Microalbumin, 24-HR Urine (mg/day) (15)
CL Item
Protein, 24-HR Urine (mg/day) (16)
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
Granular Casts (25)
CL Item
Hyaline Casts (26)
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
Starch Granules (51)
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)
24-Hr Urine Collection Start Date
Item
24-Hr Urine Collection Start Date
date
C0455060 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
24-Hr Urine Collection Start Time
Item
24-Hr Urine Collection Start Time
time
C0455060 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
24-Hr Urine Collection Stop Date
Item
24-Hr Urine Collection Stop Date
date
C0455060 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
24-Hr Urine Collection Stop Time
Item
24-Hr Urine Collection Stop Time
time
C0455060 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
24-Hr Urine Collection Total Volume
Item
24-Hr Urine Collection Total Volume
float
C0455060 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
24-Hr Urine Collection Date Sent to Laboratory
Item
24-Hr Urine Collection Date Sent to Laboratory
date
C0455060 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
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 systolic
integer
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])
Code List
Since the last visit, did the subject have a cardiac event that meets the secondary endpoint criteria?
CL Item
Yes, please specify (1)
Item
Was the subject sent for a cardiac consult?
integer
C0009818 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
Code List
Was the subject sent for a cardiac consult?
Item
Since the last visit, did the subject have a cerebrovascular event that meets the secondary endpoint criteria?
integer
C0038454 (UMLS CUI [1])
Code List
Since the last visit, did the subject have a cerebrovascular event that meets the secondary endpoint criteria?
CL Item
Yes, please specify (1)
Item
Was the subject sent for a neurological consult?
integer
C0849229 (UMLS CUI [1])
Code List
Was the subject sent for a neurological consult?
Enzyme Replacement Therapy Infusion procedures Count
Item
Dosing: Record the total ERT Infusions since the last visit
integer
C0598391 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Item
Dosing: Were any infusions missed?
integer
C0598391 (UMLS CUI [1])
Code List
Dosing: Were any infusions missed?
Item
Enter Details of each infusion: Drug name
integer
C0013227 (UMLS CUI [1])
Code List
Enter Details of each infusion: Drug name
Date of infusion
Item
Enter Details of each infusion: Date of infusion
date
C0574032 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Prescribed Dose
Item
Enter Details of each infusion: Prescribed Dose
float
C0678766 (UMLS CUI [1])
Item
Enter Details of each infusion: Was the total volume infused?
integer
C0574032 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
Code List
Enter Details of each infusion: Was the total volume infused?
Date and time of dose of last active drug
Item
Visit Summary: Date and time of dose of last active drug
text
Did the subject take all required active study drug over the last 7 days
Item
Visit Summary: Did the subject take all required active study drug over the last 7 days?
text
C0205177 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Number of actives capsules the subject should have taken over the last 7 days
Item
Visit Summary: Number of actives capsules the subject should have taken over the last 7 days
integer
C0205177 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Number of actives capsules actually taken by the subject over the last 7 days
Item
Visit Summary: Number of actives capsules actually taken by the subject over the last 7 days
integer
C0205177 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
compliant when taking active drug
Item
Visit Summary: If the subject was not 100% compliant when taking active drug over the last 7 days - please explain.
text
C1321605 (UMLS CUI [1])
Lot number
Item
Blister pack information: Lot number
integer
C2826710 (UMLS CUI [1])
Blister pack number
Item
Blister pack information: Blister pack number
integer
C1706080 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Date Dispensed
Item
Blister pack information: Date Dispensed
date
C0011008 (UMLS CUI [1])
Number of active capsules dispensed
Item
Blister pack information: Number of active capsules dispensed
integer
C0805077 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
Date of first dose from blister pack
Item
Blister pack information: Date of first dose from blister pack
date
C3173309 (UMLS CUI [1])
Date blister pack returned
Item
Blister pack information: Date blister pack returned
date
C0011008 (UMLS CUI [1])
Number of active drug capsules to be taken
Item
Blister pack information: Number of active drug capsules to be taken
integer
C0205177 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Actual number of active drug capsules taken
Item
Blister pack information: Actual number of active drug capsules taken
integer
C0205177 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Number of active capsules returned
Item
Blister pack information: Number of active capsules returned
integer
C0205177 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Dates of missed active doses
Item
Blister pack information: Dates of missed active doses
date
C0011008 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])