ID

37640

Descripción

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

Palabras clave

Versiones (1)
  1. 12/8/19 12/8/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de agosto de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Cycle 1

1 formularios  
  1. StudyEvent: ODM
    1. Cycle 1
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Descripción

Patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
Day 1
Descripción

Day 1

Alias
UMLS CUI-1
C0011298
Weight
Descripción

Body Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Descripción

Body Surface Area

Tipo de datos

float

Unidades de medida
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Administration of study medication topotecan
Descripción

Administration of study medication topotecan

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

Experimental drug, Topotecan, Administration of medication, Day

Tipo de datos

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
Descripción

Experimental drug, Topotecan, Daily Dose, Planned

Tipo de datos

text

Unidades de medida
  • 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
Descripción

Experimental drug, Topotecan, Daily Dose, Total

Tipo de datos

integer

Unidades de medida
  • 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
Descripción

Experimental drug, Topotecan, Administration of medication, Start Date

Tipo de datos

date

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

Experimental drug, Topotecan, Administration of medication, Start Time

Tipo de datos

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)
Descripción

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
Descripción

Experimental drug, Carboplatin, Administration of medication, Day

Tipo de datos

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
Descripción

Experimental drug, Carboplatin, Daily Dose, Planned

Tipo de datos

text

Unidades de medida
  • 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
Descripción

Experimental drug, Carboplatin, Daily Dose, Total

Tipo de datos

integer

Unidades de medida
  • 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
Descripción

Experimental drug, Carboplatin, Administration of medication, Start Date

Tipo de datos

date

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

Experimental drug, Carboplatin, Administration of medication, Start Time

Tipo de datos

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
Descripción

Laboratory Values - Hematology

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

Laboratory Procedures, Hematology finding, Visit

Tipo de datos

text

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

Laboratory Procedures, Hematology finding, Sampling, Date in time

Tipo de datos

date

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

Laboratory Procedures, Hematology finding, Sampling, Time

Tipo de datos

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
Descripción

Laboratory Procedures, Hematology finding, Performing laboratory name

Tipo de datos

text

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

Laboratory Procedures, Hematology finding, Laboratory, Code

Tipo de datos

text

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

Laboratory Procedures, Hematology finding, Parameter Value

Tipo de datos

text

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

Laboratory Procedures, Hematology finding, Result

Tipo de datos

text

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

Laboratory Procedures, Hematology finding, Result, Clinical Significance

Tipo de datos

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
Descripción

Laboratory Values - Clinical Chemistry

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

Laboratory Procedures, Chemistry, Clinical, Visit

Tipo de datos

text

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

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

Tipo de datos

date

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

Laboratory Procedures, Chemistry, Clinical, Sampling, Time

Tipo de datos

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
Descripción

Laboratory Procedures, Chemistry, Clinical, Performing laboratory name

Tipo de datos

text

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

Laboratory Procedures, Chemistry, Clinical, Laboratory, Code

Tipo de datos

text

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

Laboratory Procedures, Chemistry, Clinical, Parameter Value

Tipo de datos

text

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

Laboratory Procedures, Chemistry, Clinical, Result

Tipo de datos

text

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

Laboratory Procedures, Chemistry, Clinical, Result, Clinical Significance

Tipo de datos

boolean

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

Urinalysis

Alias
UMLS CUI-1
C0042014
Visit
Descripción

Laboratory Procedures, Urinalysis, Visit

Tipo de datos

text

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

Laboratory Procedures, Urinalysis, Sampling, Date in time

Tipo de datos

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
Descripción

Laboratory Procedures, Urinalysis, Performing laboratory name

Tipo de datos

text

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

Laboratory Procedures, Urinalysis, Laboratory, Code

Tipo de datos

text

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

Laboratory Procedures, Urinalysis, Parameter Value

Tipo de datos

text

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

Laboratory Procedures, Urinalysis, Result

Tipo de datos

text

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

Laboratory Procedures, Urinalysis, Microscopic urinalysis

Tipo de datos

boolean

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

Laboratory Procedures, Urinalysis, Result, Clinical Significance

Tipo de datos

boolean

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

Concomitant Medication

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

Concomitant Agent

Tipo de datos

boolean

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

Concomitant Agent, Medication name

Tipo de datos

text

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

Concomitant Medication Daily Dose, Total

Tipo de datos

text

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

Concomitant Agent, Drug Administration Routes

Tipo de datos

text

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

Concomitant Agent, Indication

Tipo de datos

text

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

Concomitant Medication Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826734
Stop date
Descripción

Concomitant Medication End Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826744
Mark if ongoing
Descripción

Concomitant Medication Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Cycle 1

1 formularios
  1. StudyEvent: ODM
    1. Cycle 1
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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