ID

39069

Beschreibung

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the Laboratories form. It contains the clinical chemistry, renal assessment, clinical haematology, clinical coagulaion and the blood smear result. It has to be filled in for screening and Day 1, for all visits of part 2 and part 3. Clinical chemistry and haematology also has to be filled in for thw weekly follow-up visits.

Link

https://clinicaltrials.gov/ct2/show/NCT00908037

Stichworte

Versionen (2)
  1. 17.10.19 17.10.19 -
  2. 26.11.19 26.11.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

26. November 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

Englisch

Laboratories

1 Formulare  
  1. StudyEvent: ODM
    1. Laboratories
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit type
Beschreibung

If you tick "P1W24/EW", "P3W24/EW" or "P3W31/EW" please check in the following item if this is an early withdrawal. For the follow-up Visits only the clinical chemistry and haematology have to be filled in.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Early withdrawal
Beschreibung

Early withdrawal

Datentyp

boolean

Alias
UMLS CUI [1]
C2349954
Lab name and address Clinical chemistry
Beschreibung

Lab name and address Clinical chemistry

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C1442065
UMLS CUI-3
C0027365
UMLS CUI-4
C0008000
Laboratory ID
Beschreibung

Laboratory ID

Datentyp

text

Alias
UMLS CUI [1]
C2986056
Laboratory name
Beschreibung

Laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Laboratory Address
Beschreibung

Laboratory Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Clinical chemistry
Beschreibung

Clinical chemistry

Alias
UMLS CUI-1
C0008000
Date sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Clinical chemistry procedure
Beschreibung

Fill in this itemgroup for each analyte.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
Clinical chemistry procedure, Result
Beschreibung

If you tick "Numeric result" and/or "Character result", fill in for both if clinically significant in the appropriate items.

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1274040
Numeric result
Beschreibung

Numeric result

Datentyp

float

Alias
UMLS CUI [1]
C2347373
Numeric result, Clinical significance
Beschreibung

Numeric result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C2347373
Character result
Beschreibung

Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C2350015
UMLS CUI [1,2]
C1274040
Character result, Clinical significance
Beschreibung

Character result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C2350015
Lab name and address renal assessment
Beschreibung

Lab name and address renal assessment

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C1442065
UMLS CUI-3
C0027365
UMLS CUI-4
C0022646
UMLS CUI-5
C1516048
Laboratory ID
Beschreibung

Laboratory ID

Datentyp

text

Alias
UMLS CUI [1]
C2986056
Laboratory name
Beschreibung

Laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Laboratory Address
Beschreibung

Laboratory Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Renal assessment - Dipstick details
Beschreibung

Renal assessment - Dipstick details

Alias
UMLS CUI-1
C0022646
UMLS CUI-2
C1516048
UMLS CUI-3
C0430370
Date sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Dipstick details
Beschreibung

Fill in this itemgroup for each analyte.

Datentyp

integer

Alias
UMLS CUI [1]
C0430370
Dipstick details, Result
Beschreibung

If you tick "Numeric result" and/or "Character result", fill in for both if clinically significant in the appropriate items.

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Numeric result
Beschreibung

Numeric result

Datentyp

float

Alias
UMLS CUI [1]
C2347373
Numeric result, Clinical significance
Beschreibung

Numeric result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0022646
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C2347373
Character result
Beschreibung

Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C2350015
UMLS CUI [1,2]
C1274040
Character result, Clinical significance
Beschreibung

Character result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0022646
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C2350015
Renal assessment - Microscopy details
Beschreibung

Renal assessment - Microscopy details

Alias
UMLS CUI-1
C0022646
UMLS CUI-2
C1516048
UMLS CUI-3
C0430397
Microscopy details
Beschreibung

Fill in this itemgroup for each finding.

Datentyp

integer

Alias
UMLS CUI [1]
C0430397
Microscopy details, Result
Beschreibung

If you tick "Numeric result" and/or "Character result", fill in for both if clinically significant in the appropriate items.

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0456984
Numeric result
Beschreibung

Numeric result

Datentyp

float

Alias
UMLS CUI [1]
C2347373
Numeric result, Clinical significance
Beschreibung

Numeric result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0022646
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C2347373
Character result
Beschreibung

Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C2350015
UMLS CUI [1,2]
C1274040
Character result, Clinical significance
Beschreibung

Character result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0022646
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C2350015
Creatinine Clearance
Beschreibung

Creatinine Clearance

Alias
UMLS CUI-1
C0373595
Creatinine Clearance, Result
Beschreibung

If you tick "Numeric result" and/or "Character result", fill in for both if clinically significant in the appropriate items.

Datentyp

text

Alias
UMLS CUI [1,1]
C0373595
UMLS CUI [1,2]
C0456984
Numeric result
Beschreibung

Numeric result

Datentyp

float

Alias
UMLS CUI [1]
C2347373
Numeric result, Clinical significance
Beschreibung

Numeric result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0373595
UMLS CUI [1,3]
C2347373
Character result
Beschreibung

Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C2350015
UMLS CUI [1,2]
C1274040
Character result, Clinical significance
Beschreibung

Character result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0373595
UMLS CUI [1,3]
C2350015
Urine Total Protein/Creatinine Ratio
Beschreibung

Urine Total Protein/Creatinine Ratio

Alias
UMLS CUI-1
C1096054
Urine Total Protein/Creatinine Ratio, Result
Beschreibung

If you tick "Numeric result" and/or "Character result", fill in for both if clinically significant in the appropriate items.

Datentyp

text

Alias
UMLS CUI [1,1]
C1096054
UMLS CUI [1,2]
C0456984
Numeric result
Beschreibung

Numeric result

Datentyp

float

Alias
UMLS CUI [1]
C2347373
Numeric result, Clinical significance
Beschreibung

Numeric result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C1096054
UMLS CUI [1,3]
C2347373
Character result
Beschreibung

Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C2350015
UMLS CUI [1,2]
C1274040
Character result, Clinical significance
Beschreibung

Character result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C1096054
UMLS CUI [1,3]
C2350015
Urine Protein Electrophoresis
Beschreibung

Urine Protein Electrophoresis

Alias
UMLS CUI-1
C0201721
Urine Protein Electrophoresis, Result
Beschreibung

(if UP/C is abnormal) If you tick "Numeric result" and/or "Character result", fill in for both if clinically significant in the appropriate items.

Datentyp

text

Alias
UMLS CUI [1,1]
C0201721
UMLS CUI [1,2]
C0456984
Numeric result
Beschreibung

Numeric result

Datentyp

float

Alias
UMLS CUI [1]
C2347373
Numeric result, Clinical significance
Beschreibung

Numeric result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0201721
UMLS CUI [1,3]
C2347373
Character result
Beschreibung

Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C2350015
UMLS CUI [1,2]
C1274040
Character result, Clinical significance
Beschreibung

Character result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0201721
UMLS CUI [1,3]
C2350015
Albumin
Beschreibung

Albumin

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0201838
UMLS CUI [1,2]
C0201721
%
Alpha 1 globulin
Beschreibung

Alpha 1 globulin

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0860678
UMLS CUI [1,2]
C0201721
%
Alpha 2 globulin
Beschreibung

Alpha 2 globulin

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0855580
UMLS CUI [1,2]
C0201721
%
Beta globulin
Beschreibung

Beta globulin

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0005157
UMLS CUI [1,2]
C0201721
%
Gamma globulin
Beschreibung

Gamma globulin

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0860681
UMLS CUI [1,2]
C0201721
%
Lab name and address hematology
Beschreibung

Lab name and address hematology

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C1442065
UMLS CUI-3
C0027365
UMLS CUI-4
C0474523
Laboratory ID
Beschreibung

Laboratory ID

Datentyp

text

Alias
UMLS CUI [1]
C2986056
Laboratory name
Beschreibung

Laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Laboratory Address
Beschreibung

Laboratory Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Haematology
Beschreibung

Haematology

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0022885
Date sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Haematology test
Beschreibung

Note: for Reticulocytes: Enter only if hemoglobin <10 g/dl; otherwise enter No result. Fill in this itemgroup for each test.

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Haematology test, Result
Beschreibung

If you tick "Numeric result" and/or "Character result", fill in for both if clinically significant in the appropriate items.

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1274040
Numeric result
Beschreibung

Numeric result

Datentyp

float

Alias
UMLS CUI [1]
C2347373
Numeric result, Clinical significance
Beschreibung

Numeric result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C2347373
Character result
Beschreibung

Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C2350015
UMLS CUI [1,2]
C1274040
Character result, Clinical significance
Beschreibung

Character result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C2350015
Lab name and address coagulation
Beschreibung

Lab name and address coagulation

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C1442065
UMLS CUI-3
C0027365
UMLS CUI-4
C0005778
Laboratory ID
Beschreibung

Laboratory ID

Datentyp

text

Alias
UMLS CUI [1]
C2986056
Laboratory name
Beschreibung

Laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Laboratory Address
Beschreibung

Laboratory Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Coagulation
Beschreibung

Coagulation

Alias
UMLS CUI-1
C0005778
Date sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Coagulation test
Beschreibung

Fill in this itemgroup for each test.

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Coagulation test, Result
Beschreibung

If you tick "Numeric result" and/or "Character result", fill in for both if clinically significant in the appropriate items.

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005790
UMLS CUI [1,3]
C1274040
Numeric result
Beschreibung

Numeric result

Datentyp

float

Alias
UMLS CUI [1]
C2347373
Numeric result, Clinical significance
Beschreibung

Numeric result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0005778
UMLS CUI [1,3]
C2347373
Character result
Beschreibung

Character result

Datentyp

text

Alias
UMLS CUI [1,1]
C2350015
UMLS CUI [1,2]
C1274040
Character result, Clinical significance
Beschreibung

Character result, Clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C2826293
UMLS CUI [1,2]
C0005778
UMLS CUI [1,3]
C2350015
Lab name and address blood smear
Beschreibung

Lab name and address blood smear

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C1442065
UMLS CUI-3
C0027365
UMLS CUI-4
C2238079
Laboratory ID
Beschreibung

Laboratory ID

Datentyp

text

Alias
UMLS CUI [1]
C2986056
Laboratory name
Beschreibung

Laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Laboratory Address
Beschreibung

Laboratory Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Blood smear results
Beschreibung

Blood smear results

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C2238079
Date of Blood Smear
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C2238079
UMLS CUI [1,2]
C0011008
Does blood smear confirm presence of immature or dysplastic cells?
Beschreibung

Immature, dysplastic cells

Datentyp

text

Alias
UMLS CUI [1]
C0205252
UMLS CUI [2,1]
C0334044
UMLS CUI [2,2]
C0007634
Blood smear cells
Beschreibung

Fill in this itemgroup for each cell type.

Datentyp

integer

Alias
UMLS CUI [1,1]
C2238079
UMLS CUI [1,2]
C0007634
Blood smear result
Beschreibung

Fill in for each cell type listed. If there is no result, tick the following item. If there is an other result, please specify in the item "Other blood smear result".

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2238079
%
No result
Beschreibung

Tick for each cell if there is no result.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C1298908
Other blood smear result
Beschreibung

Other blood smear result

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C2238079
UMLS CUI [1,4]
C2348235
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Ähnliche Modelle

Laboratories

1 Formulare
  1. StudyEvent: ODM
    1. Laboratories
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
Day 1 (2)
CL Item
P1W1 (3)
CL Item
P1W2 (4)
CL Item
P1W3 (5)
CL Item
P1W4 (6)
CL Item
P1W5 (7)
CL Item
P1W6 (8)
CL Item
P1W7 (9)
CL Item
P1W8-23 (10)
CL Item
P1W24/EW (11)
CL Item
P2W1 (12)
CL Item
P2W2 (13)
CL Item
P2W3 (14)
CL Item
P2W4 (15)
CL Item
P2W5 (16)
CL Item
P2W6 (17)
CL Item
P2W7 (18)
CL Item
P3W8-23 (19)
CL Item
P3W8-30 (20)
CL Item
P3W24/EW (21)
CL Item
P3W31/EW (22)
CL Item
FUW1 (23)
CL Item
FUW2 (24)
CL Item
FUW3 (25)
CL Item
FUW4 (26)
CL Item
Unscheduled (27)
Early withdrawal
Item
Early withdrawal
boolean
C2349954 (UMLS CUI [1])
Item Group
Lab name and address Clinical chemistry
C0022877 (UMLS CUI-1)
C1442065 (UMLS CUI-2)
C0027365 (UMLS CUI-3)
C0008000 (UMLS CUI-4)
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Laboratory Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item Group
Clinical chemistry
C0008000 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Clinical chemistry procedure
integer
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Clinical chemistry procedure
Code List
Clinical chemistry procedure
CL Item
Urea (1)
CL Item
Creatinine (2)
CL Item
Sodium (3)
CL Item
Potassium (4)
CL Item
Glucose (5)
CL Item
AST (6)
CL Item
ALT (7)
CL Item
Total Bilirubin (8)
CL Item
Direct Bilirubin (9)
CL Item
Alkaline Phosphatase (10)
CL Item
Albumin (11)
Item
Clinical chemistry procedure, Result
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Clinical chemistry procedure
Code List
Clinical chemistry procedure, Result
CL Item
Numeric result (N)
CL Item
Character result (C)
CL Item
No result (99)
Numeric result
Item
Numeric result
float
C2347373 (UMLS CUI [1])
Item
Numeric result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Clinicially significance
Code List
Numeric result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Character result
Item
Character result
text
C2350015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Character result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Clinicially significance
Code List
Character result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Lab name and address renal assessment
C0022877 (UMLS CUI-1)
C1442065 (UMLS CUI-2)
C0027365 (UMLS CUI-3)
C0022646 (UMLS CUI-4)
C1516048 (UMLS CUI-5)
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Laboratory Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item Group
Renal assessment - Dipstick details
C0022646 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
C0430370 (UMLS CUI-3)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Dipstick details
integer
C0430370 (UMLS CUI [1])
Dipstick details
Code List
Dipstick details
CL Item
pH (1)
CL Item
Glucose (2)
CL Item
Protein (3)
CL Item
Blood (4)
CL Item
Ketones (5)
Item
Dipstick details, Result
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Dipstick details, Result
Code List
Dipstick details, Result
CL Item
Numeric result (N)
CL Item
Character result (C)
CL Item
No result (99)
Numeric result
Item
Numeric result
float
C2347373 (UMLS CUI [1])
Item
Numeric result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,4])
Clinicially significance
Code List
Numeric result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Character result
Item
Character result
text
C2350015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Character result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C2350015 (UMLS CUI [1,4])
Clinicially significance
Code List
Character result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Renal assessment - Microscopy details
C0022646 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
C0430397 (UMLS CUI-3)
Item
Microscopy details
integer
C0430397 (UMLS CUI [1])
Dipstick details
Code List
Microscopy details
CL Item
Epithelial Renal Tubular Cell Casts (1)
CL Item
WBC Casts (2)
CL Item
RBC Casts (3)
Item
Microscopy details, Result
text
C0430397 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Dipstick details, Result
Code List
Microscopy details, Result
CL Item
Numeric result (N)
CL Item
Character result (C)
CL Item
No result (99)
Numeric result
Item
Numeric result
float
C2347373 (UMLS CUI [1])
Item
Numeric result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,4])
Clinicially significance
Code List
Numeric result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Character result
Item
Character result
text
C2350015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Character result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C2350015 (UMLS CUI [1,4])
Clinicially significance
Code List
Character result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Creatinine Clearance
C0373595 (UMLS CUI-1)
Item
Creatinine Clearance, Result
text
C0373595 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Dipstick details, Result
Code List
Creatinine Clearance, Result
CL Item
Numeric result (N)
CL Item
Character result (C)
CL Item
No result (99)
Numeric result
Item
Numeric result
float
C2347373 (UMLS CUI [1])
Item
Numeric result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Clinicially significance
Code List
Numeric result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Character result
Item
Character result
text
C2350015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Character result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Clinicially significance
Code List
Character result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Urine Total Protein/Creatinine Ratio
C1096054 (UMLS CUI-1)
Item
Urine Total Protein/Creatinine Ratio, Result
text
C1096054 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Dipstick details, Result
Code List
Urine Total Protein/Creatinine Ratio, Result
CL Item
Numeric result (N)
CL Item
Character result (C)
CL Item
No result (99)
Numeric result
Item
Numeric result
float
C2347373 (UMLS CUI [1])
Item
Numeric result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C1096054 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Clinicially significance
Code List
Numeric result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Character result
Item
Character result
text
C2350015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Character result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C1096054 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Clinicially significance
Code List
Character result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Urine Protein Electrophoresis
C0201721 (UMLS CUI-1)
Item
Urine Protein Electrophoresis, Result
text
C0201721 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Dipstick details, Result
Code List
Urine Protein Electrophoresis, Result
CL Item
Numeric result (N)
CL Item
Character result (C)
CL Item
No result (99)
Numeric result
Item
Numeric result
float
C2347373 (UMLS CUI [1])
Item
Numeric result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0201721 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Clinicially significance
Code List
Numeric result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Character result
Item
Character result
text
C2350015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Character result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0201721 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Clinicially significance
Code List
Character result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1,1])
C0201721 (UMLS CUI [1,2])
Alpha 1 globulin
Item
Alpha 1 globulin
float
C0860678 (UMLS CUI [1,1])
C0201721 (UMLS CUI [1,2])
Alpha 2 globulin
Item
Alpha 2 globulin
float
C0855580 (UMLS CUI [1,1])
C0201721 (UMLS CUI [1,2])
Beta globulin
Item
Beta globulin
float
C0005157 (UMLS CUI [1,1])
C0201721 (UMLS CUI [1,2])
Gamma globulin
Item
Gamma globulin
float
C0860681 (UMLS CUI [1,1])
C0201721 (UMLS CUI [1,2])
Item Group
Lab name and address hematology
C0022877 (UMLS CUI-1)
C1442065 (UMLS CUI-2)
C0027365 (UMLS CUI-3)
C0474523 (UMLS CUI-4)
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Laboratory Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item Group
Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Haematology test
integer
C0018941 (UMLS CUI [1])
Haematology test
Code List
Haematology test
CL Item
Platelets (1)
CL Item
Mean Platelet Volume (2)
CL Item
RBC (3)
CL Item
Hemoglobin (4)
CL Item
Reticulocytes (5)
CL Item
Hematocrit (6)
CL Item
WBC (7)
CL Item
Neutrophils (absolute numbers only) (8)
CL Item
Lymphocytes (absolute numbers only) (9)
CL Item
Monocytes (absolute numbers only) (10)
CL Item
Eosinophils (absolute numbers only) (11)
CL Item
Basophils (absolute numbers only) (12)
Item
Haematology test, Result
text
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Clinical chemistry procedure
Code List
Haematology test, Result
CL Item
Numeric result (N)
CL Item
Character result (C)
CL Item
No result (99)
Numeric result
Item
Numeric result
float
C2347373 (UMLS CUI [1])
Item
Numeric result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Clinicially significance
Code List
Numeric result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Character result
Item
Character result
text
C2350015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Character result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Clinicially significance
Code List
Character result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Lab name and address coagulation
C0022877 (UMLS CUI-1)
C1442065 (UMLS CUI-2)
C0027365 (UMLS CUI-3)
C0005778 (UMLS CUI-4)
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Laboratory Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item Group
Coagulation
C0005778 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Coagulation test
integer
C0018941 (UMLS CUI [1])
Haematology test
Code List
Coagulation test
CL Item
INR (1)
CL Item
PT (2)
CL Item
PTT (3)
Item
Coagulation test, Result
text
C0022885 (UMLS CUI [1,1])
C0005790 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Clinical chemistry procedure
Code List
Coagulation test, Result
CL Item
Numeric result (N)
CL Item
Character result (C)
CL Item
No result (99)
Numeric result
Item
Numeric result
float
C2347373 (UMLS CUI [1])
Item
Numeric result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0005778 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Clinicially significance
Code List
Numeric result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Character result
Item
Character result
text
C2350015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Character result, Clinical significance
text
C2826293 (UMLS CUI [1,1])
C0005778 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Clinicially significance
Code List
Character result, Clinical significance
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Lab name and address blood smear
C0022877 (UMLS CUI-1)
C1442065 (UMLS CUI-2)
C0027365 (UMLS CUI-3)
C2238079 (UMLS CUI-4)
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Laboratory Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item Group
Blood smear results
C1254595 (UMLS CUI-1)
C2238079 (UMLS CUI-2)
Date of Blood Smear
Item
Date of Blood Smear
date
C2238079 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Does blood smear confirm presence of immature or dysplastic cells?
text
C0205252 (UMLS CUI [1])
C0334044 (UMLS CUI [2,1])
C0007634 (UMLS CUI [2,2])
Clinicially significance
Code List
Does blood smear confirm presence of immature or dysplastic cells?
CL Item
Yes (Y)
CL Item
No (N)
Item
Blood smear cells
integer
C2238079 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
Blood smear results
Code List
Blood smear cells
CL Item
Myeloblasts (1)
CL Item
Promyelocytes (2)
CL Item
Metamyelocytes (3)
CL Item
Myelocytes (4)
CL Item
Neutrophils (5)
CL Item
Eosinophils (6)
CL Item
Basophils (7)
CL Item
Monocytes (8)
CL Item
Nucleated Re Blood Cells (9)
CL Item
Other Blood Smear Results (10)
Blood smear result
Item
Blood smear result
float
C1254595 (UMLS CUI [1,1])
C2238079 (UMLS CUI [1,2])
No result
Item
No result
boolean
C1274040 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
Other blood smear result
Item
Other blood smear result
text
C0205394 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C2238079 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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