ID

29865

Descripción

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Link

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Palabras clave

Versiones (1)
  1. 24/4/18 24/4/18 - Halim Ugurlu
Titular de derechos de autor

GSK

Subido en

24 de abril de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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GSK Study ID 104864-201-Medication (next Course)

Inglés

Medication

1 formularios  
  1. StudyEvent: ODM
    1. Medication
Identification Numbers
Descripción

Identification Numbers

Alias
UMLS CUI-1
C1300638
Center Number
Descripción

Center Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Descripción

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Topotecan and Ara-C Study Medication Record
Descripción

Topotecan and Ara-C Study Medication Record

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
UMLS CUI-3
C0146224
UMLS CUI-4
C0733521
Weight
Descripción

Record the patient's weight below, on Day 1 of infusion

Tipo de datos

text

Alias
UMLS CUI [1]
C0005910
Body Surface Area
Descripción

Record the patient's body surface area below, on Day 1 of infusion

Tipo de datos

float

Unidades de medida
  • m^2
Alias
UMLS CUI [1]
C0005902
m^2
Ideal Weight
Descripción

Ideal Weight

Tipo de datos

text

Alias
UMLS CUI [1]
C0421272
Ideal Weight Was Used
Descripción

Please mark the box below if the ideal weight was used to calculate body surface area.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0421272
Topotecan Administration
Descripción

Topotecan Administration

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

Day

Tipo de datos

text

Alias
UMLS CUI [1]
C0439228
Totally Daily Dose for this Infusion
Descripción

Totally Daily Dose for this Infusion

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C2348070
mg
Infusion start date
Descripción

Infusion start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0439659
Infusion Start time
Descripción

Infusion Start time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0040223
Infusion Stop date
Descripción

Infusion Stop date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0574032
Infusion Stop time
Descripción

Infusion Stop time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0040223
Ara-C Administration
Descripción

Ara-C Administration

Alias
UMLS CUI-1
C0733521
UMLS CUI-2
C3469597
Day
Descripción

Day

Tipo de datos

text

Alias
UMLS CUI [1]
C0439228
Totally Daily Dose for this Infusion
Descripción

Totally Daily Dose for this Infusion

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C2348070
mg
Infusion start date
Descripción

Infusion start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0439659
Infusion Start time
Descripción

Infusion Start time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0040223
Infusion Stop date
Descripción

Infusion Stop date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0574032
Infusion Stop time
Descripción

Infusion Stop time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0040223
Idarubicin and Ara-C Study Medication Record
Descripción

Idarubicin and Ara-C Study Medication Record

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
UMLS CUI-3
C0020789
UMLS CUI-4
C0020789
Weight
Descripción

Record the patient's weight below, on Day 1 of infusion

Tipo de datos

text

Alias
UMLS CUI [1]
C0005910
Body Surface Area
Descripción

Record the patient's body surface area below, on Day 1 of infusion

Tipo de datos

float

Unidades de medida
  • m^2
Alias
UMLS CUI [1]
C0005902
m^2
Ideal Weight
Descripción

Ideal Weight

Tipo de datos

text

Alias
UMLS CUI [1]
C0421272
Ideal Weight Was Used
Descripción

Please mark the box below if the ideal weight was used to calculate body surface area.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0421272
Idarubicin Administration
Descripción

Idarubicin Administration

Alias
UMLS CUI-1
C0013153
UMLS CUI-2
C0020789
Day
Descripción

Day

Tipo de datos

text

Alias
UMLS CUI [1]
C0439228
Totally Daily Dose for this Infusion
Descripción

Totally Daily Dose for this Infusion

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C2348070
mg
Infusion start date
Descripción

Infusion start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0439659
Infusion Start time
Descripción

Infusion Start time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0040223
Infusion Stop date
Descripción

Infusion Stop date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0574032
Infusion Stop time
Descripción

Infusion Stop time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0040223
Ara-C Administration
Descripción

Ara-C Administration

Alias
UMLS CUI-1
C0733521
UMLS CUI-2
C3469597
Day
Descripción

Day

Tipo de datos

text

Alias
UMLS CUI [1]
C0439228
Totally Daily Dose for this Infusion
Descripción

Totally Daily Dose for this Infusion

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C2348070
mg
Infusion start date
Descripción

Infusion start date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0439659
Infusion Start time
Descripción

Infusion Start time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0040223
Infusion Stop date
Descripción

Infusion Stop date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0574032
Infusion Stop time
Descripción

Infusion Stop time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0040223
Dose Reduction
Descripción

Dose Reduction

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C0547047
Was the dose reduced compared to previous course?
Descripción

For any patient who does not have CR at course 1 and who has grade 3 or 4 non-hematologic toxicity (excluding toxicities of nausea, vomiting or alopecia) may receive a 25% dose reduction at course 2 only. Refer to protocol Section 6.2.3

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0547047
If Yes to Dose Reduction, reason, (if applicable, mark more than one box below)
Descripción

If Yes to Dose Reduction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0547047
Retreatment Interval
Descripción

Retreatment Interval

Alias
UMLS CUI-1
C0376495
UMLS CUI-2
C1272706
Was the patient treated at 4 week (28 day) interval?
Descripción

Retreatment Interval

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0376495
UMLS CUI [1,2]
C1272706
If 'No' please indicate the retreatment interval below
Descripción

If No to

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0376495
UMLS CUI [1,2]
C1272706
UMLS CUI [1,3]
C1518422
Approved by
Descripción

Approved by

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Date of Approve
Descripción

Date of Approve

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
G-CSF Study Medication Record
Descripción

G-CSF Study Medication Record

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
UMLS CUI-3
C0079459
Day
Descripción

Day 14 to 28

Tipo de datos

text

Alias
UMLS CUI [1]
C0439228
Dose
Descripción

Dose

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0079459
Route
Descripción

Route

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0079459
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Time
Descripción

Time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Vital Signs-TAG Regiment only
Descripción

Vital Signs-TAG Regiment only

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0146224
UMLS CUI-3
C0733521
UMLS CUI-4
C0079459
UMLS CUI-5
C0013227
Day
Descripción

Day

Tipo de datos

text

Alias
UMLS CUI [1]
C0439228
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Scheduled Time
Descripción

Prior to infusion

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Actual Time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0237400
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
Descripción

Sitting Blood Pressure (Systolic) After 5 Minutes Sitting

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
Descripción

Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Pulse After 5 Minutes Sitting
Descripción

Pulse After 5 Minutes Sitting

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0277814
beats/min
Vital Signs-IDAG Regiment only-Vital signs are to be performed on Days 1, 2, and 3 prior to idarubicin infusion and post ara-C infusion. On Days 4 and 5, vital signs are to be performed prior and post ara-C infusion
Descripción

Vital Signs-IDAG Regiment only-Vital signs are to be performed on Days 1, 2, and 3 prior to idarubicin infusion and post ara-C infusion. On Days 4 and 5, vital signs are to be performed prior and post ara-C infusion

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0020789
UMLS CUI-3
C0733521
UMLS CUI-4
C0079459
UMLS CUI-5
C0013227
Day
Descripción

Day

Tipo de datos

text

Alias
UMLS CUI [1]
C0439228
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Scheduled Time
Descripción

Prior to infusion

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1301732
Actual Time
Descripción

Actual Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0237400
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
Descripción

Sitting Blood Pressure (Systolic) After 5 Minutes Sitting

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
Descripción

Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Pulse After 5 Minutes Sitting
Descripción

Pulse After 5 Minutes Sitting

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0277814
beats/min
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Similar models

Medication

1 formularios
  1. StudyEvent: ODM
    1. Medication
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Identification Numbers
C1300638 (UMLS CUI-1)
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Topotecan and Ara-C Study Medication Record
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0146224 (UMLS CUI-3)
C0733521 (UMLS CUI-4)
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
Body Surface Area
Item
Body Surface Area
float
C0005902 (UMLS CUI [1])
Ideal Weight
Item
Ideal Weight
text
C0421272 (UMLS CUI [1])
Ideal Weight Was Used
Item
Ideal Weight Was Used
boolean
C0421272 (UMLS CUI [1])
Item Group
Topotecan Administration
C3469597 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Totally Daily Dose for this Infusion
Item
Totally Daily Dose for this Infusion
float
C2348070 (UMLS CUI [1])
Infusion start date
Item
Infusion start date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start time
Item
Infusion Start time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop date
Item
Infusion Stop date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop time
Item
Infusion Stop time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Ara-C Administration
C0733521 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Totally Daily Dose for this Infusion
Item
Totally Daily Dose for this Infusion
float
C2348070 (UMLS CUI [1])
Infusion start date
Item
Infusion start date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start time
Item
Infusion Start time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop date
Item
Infusion Stop date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop time
Item
Infusion Stop time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Idarubicin and Ara-C Study Medication Record
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0020789 (UMLS CUI-3)
C0020789 (UMLS CUI-4)
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
Body Surface Area
Item
Body Surface Area
float
C0005902 (UMLS CUI [1])
Ideal Weight
Item
Ideal Weight
text
C0421272 (UMLS CUI [1])
Ideal Weight Was Used
Item
Ideal Weight Was Used
boolean
C0421272 (UMLS CUI [1])
Item Group
Idarubicin Administration
C0013153 (UMLS CUI-1)
C0020789 (UMLS CUI-2)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Totally Daily Dose for this Infusion
Item
Totally Daily Dose for this Infusion
float
C2348070 (UMLS CUI [1])
Infusion start date
Item
Infusion start date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start time
Item
Infusion Start time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop date
Item
Infusion Stop date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop time
Item
Infusion Stop time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Ara-C Administration
C0733521 (UMLS CUI-1)
C3469597 (UMLS CUI-2)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Totally Daily Dose for this Infusion
Item
Totally Daily Dose for this Infusion
float
C2348070 (UMLS CUI [1])
Infusion start date
Item
Infusion start date
date
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Infusion Start time
Item
Infusion Start time
time
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Infusion Stop date
Item
Infusion Stop date
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Infusion Stop time
Item
Infusion Stop time
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Dose Reduction
C0178602 (UMLS CUI-1)
C0547047 (UMLS CUI-2)
Dose Reduction
Item
Was the dose reduced compared to previous course?
boolean
C0178602 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Item
If Yes to Dose Reduction, reason, (if applicable, mark more than one box below)
text
C0178602 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
If Yes to Dose Reduction
Code List
If Yes to Dose Reduction, reason, (if applicable, mark more than one box below)
CL Item
Grade 3 or 4 non-hematologic toxicity ->Record in the Adverse Experience section (2)
CL Item
Consolidation (3)
CL Item
Other, specify:...................... (4)
Item Group
Retreatment Interval
C0376495 (UMLS CUI-1)
C1272706 (UMLS CUI-2)
Retreatment Interval
Item
Was the patient treated at 4 week (28 day) interval?
boolean
C0376495 (UMLS CUI [1,1])
C1272706 (UMLS CUI [1,2])
Item
If 'No' please indicate the retreatment interval below
text
C0376495 (UMLS CUI [1,1])
C1272706 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
If No to " treated at 4 week (28 day) interval"
Code List
If 'No' please indicate the retreatment interval below
CL Item
29-35 days (4-5 week interval) (1)
CL Item
36-42 days (5-6 week interval) (2)
CL Item
Other (> 42 Days or > 6 weeks), specify:............................... Specify reason=.............................. (3)
Approved by
Item
Approved by
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of Approve
Item
Date of Approve
date
C0011008 (UMLS CUI [1])
Item Group
G-CSF Study Medication Record
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0079459 (UMLS CUI-3)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1,1])
C0079459 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0079459 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
SC (1)
CL Item
IV (2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item Group
Vital Signs-TAG Regiment only
C0518766 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
C0733521 (UMLS CUI-3)
C0079459 (UMLS CUI-4)
C0013227 (UMLS CUI-5)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
text
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1,1])
C0237400 (UMLS CUI [1,2])
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
Item
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
Item
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Pulse After 5 Minutes Sitting
Item
Pulse After 5 Minutes Sitting
integer
C0232117 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Vital Signs-IDAG Regiment only-Vital signs are to be performed on Days 1, 2, and 3 prior to idarubicin infusion and post ara-C infusion. On Days 4 and 5, vital signs are to be performed prior and post ara-C infusion
C0518766 (UMLS CUI-1)
C0020789 (UMLS CUI-2)
C0733521 (UMLS CUI-3)
C0079459 (UMLS CUI-4)
C0013227 (UMLS CUI-5)
Day
Item
Day
text
C0439228 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Scheduled Time
Item
Scheduled Time
text
C0040223 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1,1])
C0237400 (UMLS CUI [1,2])
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
Item
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
Item
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Pulse After 5 Minutes Sitting
Item
Pulse After 5 Minutes Sitting
integer
C0232117 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
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