ID

37640

Beschreibung

Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

Stichworte

Versionen (1)
  1. 12.08.19 12.08.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. August 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612

Englisch

Cycle 1

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

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Beschreibung

Patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Day 1
Beschreibung

Day 1

Alias
UMLS CUI-1
C0011298
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Beschreibung

Body Surface Area

Datentyp

float

Maßeinheiten
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Administration of study medication topotecan
Beschreibung

Administration of study medication topotecan

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0146224
UMLS CUI-3
C3469597
Day
Beschreibung

Experimental drug, Topotecan, Administration of medication, Day

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C0439228
Planned daily dose for this infusion
Beschreibung

Experimental drug, Topotecan, Daily Dose, Planned

Datentyp

text

Maßeinheiten
  • mg/m2
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C1301732
Administered total dose of the daily infusion
Beschreibung

Experimental drug, Topotecan, Daily Dose, Total

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0439810
mg
Start date of the infusion
Beschreibung

Experimental drug, Topotecan, Administration of medication, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C3469597C0808070
Start time of the infusion
Beschreibung

Experimental drug, Topotecan, Administration of medication, Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C1301880
Administration of study medication carboplatin AUC 5 (2 h after topotecan infusion)
Beschreibung

Administration of study medication carboplatin AUC 5 (2 h after topotecan infusion)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0079083
UMLS CUI-3
C3469597
Day
Beschreibung

Experimental drug, Carboplatin, Administration of medication, Day

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0079083
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C0439228
Planned daily dose for this infusion
Beschreibung

Experimental drug, Carboplatin, Daily Dose, Planned

Datentyp

text

Maßeinheiten
  • mg/m2
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0079083
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C1301732
mg/m2
Administered total dose of the daily infusion
Beschreibung

Experimental drug, Carboplatin, Daily Dose, Total

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0079083
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0439810
mg
Start date of the infusion
Beschreibung

Experimental drug, Carboplatin, Administration of medication, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0079083
UMLS CUI [1,3]
C3469597C0808070
Start time of the infusion
Beschreibung

Experimental drug, Carboplatin, Administration of medication, Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0079083
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C1301880
Laboratory Values - Hematology
Beschreibung

Laboratory Values - Hematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Visit
Beschreibung

Laboratory Procedures, Hematology finding, Visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0545082
Sampling Date
Beschreibung

Laboratory Procedures, Hematology finding, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Time
Beschreibung

Laboratory Procedures, Hematology finding, Sampling, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Name of laboratory
Beschreibung

Laboratory Procedures, Hematology finding, Performing laboratory name

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C3258037
Lab code
Beschreibung

Laboratory Procedures, Hematology finding, Laboratory, Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0022877
UMLS CUI [1,4]
C0805701
Parameter
Beschreibung

Laboratory Procedures, Hematology finding, Parameter Value

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0549193
Result
Beschreibung

Laboratory Procedures, Hematology finding, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1274040
Any clinically significant abnormal laboratory values?
Beschreibung

Laboratory Procedures, Hematology finding, Result, Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C2826293
Laboratory Values - Clinical Chemistry
Beschreibung

Laboratory Values - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Visit
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0545082
Sampling Date
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Time
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Sampling, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Name of laboratory
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Performing laboratory name

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C3258037
Lab code
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Laboratory, Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0022877
UMLS CUI [1,4]
C0805701
Parameter
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Parameter Value

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0549193
Result
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1274040
Any clinically significant abnormal laboratory values?
Beschreibung

Laboratory Procedures, Chemistry, Clinical, Result, Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C2826293
Urinalysis
Beschreibung

Urinalysis

Alias
UMLS CUI-1
C0042014
Visit
Beschreibung

Laboratory Procedures, Urinalysis, Visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0545082
Sampling Date
Beschreibung

Laboratory Procedures, Urinalysis, Sampling, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Name of the laboratory
Beschreibung

Laboratory Procedures, Urinalysis, Performing laboratory name

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C3258037
Lab code
Beschreibung

Laboratory Procedures, Urinalysis, Laboratory, Code

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0022877
UMLS CUI [1,4]
C0805701
Parameter
Beschreibung

Laboratory Procedures, Urinalysis, Parameter Value

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0549193
Result
Beschreibung

Laboratory Procedures, Urinalysis, Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1274040
Microscopy done?
Beschreibung

Laboratory Procedures, Urinalysis, Microscopic urinalysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C0430397
Any clinically significant abnormal laboratory values?
Beschreibung

Laboratory Procedures, Urinalysis, Result, Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1274040
UMLS CUI [1,4]
C2826293
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Please document all concomitant medication administered to the patient during this cycle.
Beschreibung

Concomitant Agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Medication (trade name)
Beschreibung

Concomitant Agent, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Total Daily dose
Beschreibung

Concomitant Medication Daily Dose, Total

Datentyp

text

Alias
UMLS CUI [1,1]
C2826638
UMLS CUI [1,2]
C0439810
Mode of application
Beschreibung

Concomitant Agent, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Indication
Beschreibung

Concomitant Agent, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Start date
Beschreibung

Concomitant Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Stop date
Beschreibung

Concomitant Medication End Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Mark if ongoing
Beschreibung

Concomitant Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
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Ähnliche Modelle

Cycle 1

1 Formulare
  1. StudyEvent: ODM
    1. Cycle 1
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Item Group
Day 1
C0011298 (UMLS CUI-1)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Surface Area
Item
Body surface area
float
C0005902 (UMLS CUI [1])
Item Group
Administration of study medication topotecan
C0304229 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
C3469597 (UMLS CUI-3)
Item
Day
text
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,4])
Experimental drug, Topotecan, Administration of medication, Day
Code List
Day
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Item
Planned daily dose for this infusion
text
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Visit
Code List
Planned daily dose for this infusion
CL Item
Baseline (1)
CL Item
Day 1 (2)
CL Item
Day 8 (3)
CL Item
Day 15 (4)
Experimental drug, Topotecan, Daily Dose, Total
Item
Administered total dose of the daily infusion
integer
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0439810 (UMLS CUI [1,4])
Experimental drug, Topotecan, Administration of medication, Start Date
Item
Start date of the infusion
date
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C3469597C0808070 (UMLS CUI [1,3])
Experimental drug, Topotecan, Administration of medication, Start Time
Item
Start time of the infusion
time
C0304229 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
Item Group
Administration of study medication carboplatin AUC 5 (2 h after topotecan infusion)
C0304229 (UMLS CUI-1)
C0079083 (UMLS CUI-2)
C3469597 (UMLS CUI-3)
Item
Day
text
C0304229 (UMLS CUI [1,1])
C0079083 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,4])
Experimental drug, Topotecan, Administration of medication, Day
Code List
Day
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Experimental drug, Carboplatin, Daily Dose, Planned
Item
Planned daily dose for this infusion
text
C0304229 (UMLS CUI [1,1])
C0079083 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Experimental drug, Carboplatin, Daily Dose, Total
Item
Administered total dose of the daily infusion
integer
C0304229 (UMLS CUI [1,1])
C0079083 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0439810 (UMLS CUI [1,4])
Experimental drug, Carboplatin, Administration of medication, Start Date
Item
Start date of the infusion
date
C0304229 (UMLS CUI [1,1])
C0079083 (UMLS CUI [1,2])
C3469597C0808070 (UMLS CUI [1,3])
Experimental drug, Carboplatin, Administration of medication, Start Time
Item
Start time of the infusion
time
C0304229 (UMLS CUI [1,1])
C0079083 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
Item Group
Laboratory Values - Hematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Visit
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Visit
Code List
Visit
CL Item
Baseline (1)
CL Item
Day 1 (2)
CL Item
Day 8 (3)
CL Item
Day 15 (4)
Laboratory Procedures, Hematology finding, Sampling, Date in time
Item
Sampling Date
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Sampling, Time
Item
Time
time
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Performing laboratory name
Item
Name of laboratory
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C3258037 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Laboratory, Code
Item
Lab code
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Item
Parameter
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Parameter Value
Code List
Parameter
CL Item
Hemoglobin (1)
CL Item
Hematocrit (2)
CL Item
Erythrocytes (3)
CL Item
Leukocytes (4)
CL Item
Neutrophiles (5)
CL Item
Lymphocytes (6)
CL Item
Monocytes (7)
CL Item
Eosinophiles (8)
CL Item
Basophils (9)
CL Item
Thrombocytes (Platelets) (10)
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Parameter Value
Code List
Result
Laboratory Procedures, Hematology finding, Result, Clinical Significance
Item
Any clinically significant abnormal laboratory values?
boolean
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Item Group
Laboratory Values - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Visit
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Visit
Code List
Visit
CL Item
Baseline (1)
CL Item
Day 1 (2)
CL Item
Day 8 (3)
CL Item
Day 15 (4)
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Item
Sampling Date
date
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Sampling, Time
Item
Time
time
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Performing laboratory name
Item
Name of laboratory
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C3258037 (UMLS CUI [1,3])
Laboratory Procedures, Chemistry, Clinical, Laboratory, Code
Item
Lab code
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Item
Parameter
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Parameter Value
Code List
Parameter
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Calcium (5)
CL Item
Phosphorus (6)
CL Item
Magnesium (7)
CL Item
BUN or (8)
CL Item
Urea (9)
CL Item
Uric acid (10)
CL Item
Creatinine (11)
CL Item
alk. Phosphatase (12)
CL Item
LDH (13)
CL Item
GOT/AST (14)
CL Item
GPT/ALT (15)
CL Item
Total bilirubine (16)
CL Item
Direct bilirubine (17)
CL Item
Total protein (18)
CL Item
Albumin (19)
CL Item
Creatinine clearance (20)
Laboratory Procedures, Chemistry, Clinical, Result
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Chemistry, Clinical, Result, Clinical Significance
Item
Any clinically significant abnormal laboratory values?
boolean
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Item
Visit
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Visit
Code List
Visit
CL Item
Baseline (1)
CL Item
Day 1 (2)
Laboratory Procedures, Urinalysis, Sampling, Date in time
Item
Sampling Date
date
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Urinalysis, Performing laboratory name
Item
Name of the laboratory
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C3258037 (UMLS CUI [1,3])
Laboratory Procedures, Urinalysis, Laboratory, Code
Item
Lab code
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Item
Parameter
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
Laboratory Procedures, Hematology finding, Parameter Value
Code List
Parameter
CL Item
pH value (1)
CL Item
Glomerular filtration rate (2)
CL Item
Protein (3)
CL Item
Glucose (4)
CL Item
Blood protein (5)
CL Item
Red blood cells / HPF (6)
CL Item
White blood cells / HPF (7)
CL Item
Cylinders (casts) / LPF (8)
CL Item
Crystals /LPF (9)
Laboratory Procedures, Urinalysis, Result
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Urinalysis, Microscopic urinalysis
Item
Microscopy done?
boolean
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0430397 (UMLS CUI [1,3])
Laboratory Procedures, Urinalysis, Result, Clinical Significance
Item
Any clinically significant abnormal laboratory values?
boolean
C0022885 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Agent
Item
Please document all concomitant medication administered to the patient during this cycle.
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent, Medication name
Item
Medication (trade name)
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medication Daily Dose, Total
Item
Total Daily dose
text
C2826638 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Concomitant Agent, Drug Administration Routes
Item
Mode of application
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Agent, Indication
Item
Indication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Concomitant Medication Start Date
Item
Start date
date
C2826734 (UMLS CUI [1])
Concomitant Medication End Date
Item
Stop date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Mark if ongoing
boolean
C2826666 (UMLS CUI [1])
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