ID

30598

Descripción

Study part: Clinical Chemistry- Pitutary Coagulation GnRH. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Palabras clave

Versiones (1)
  1. 17/6/18 17/6/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

17 de junio de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Clinical Chemistry Pitutary Coagulation GnRH Pazopanib Macular Degeneration MD1103367

Inglés

Clinical Chemistry Pitutary Coagulation GnRH

1 formularios  
PITUITARY ADRENAL (PIT_ADREN)
Descripción

PITUITARY ADRENAL (PIT_ADREN)

Alias
UMLS CUI-1
C0428359
Study part
Descripción

Study part

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
Laboratory ID
Descripción

Laboratory ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2986056
Laboratory name and address
Descripción

Laboratory name address

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C1442065
Laboratory name and address
Descripción

Laboratory name address

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C1442065
Date and time sample taken
Descripción

Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Has the subject fasted?
Descripción

Fasting

Tipo de datos

text

Alias
UMLS CUI [1]
C0015663
Analysis
Descripción

Analysis

Tipo de datos

text

Alias
UMLS CUI [1]
C0936012
Result Type
Descripción

Result Type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
If Numeric result, value:
Descripción

Numeric result

Tipo de datos

integer

Alias
UMLS CUI [1]
C2347373
If Character result, value:
Descripción

Character result

Tipo de datos

text

Alias
UMLS CUI [1]
C2350015
ACTH(+ 60 min) normal/ Abnormal?
Descripción

Adrenocorticotropic hormone measurement

Tipo de datos

integer

Alias
UMLS CUI [1]
C0201835
COAGULATION (COAG)
Descripción

COAGULATION (COAG)

Alias
UMLS CUI-1
C1167912
Study part
Descripción

Study part

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
Analysis
Descripción

Analysis

Tipo de datos

text

Alias
UMLS CUI [1]
C0936012
Result Type
Descripción

Result Type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
If Numeric result, value:
Descripción

Numeric result

Tipo de datos

integer

Alias
UMLS CUI [1]
C2347373
If Character result, value:
Descripción

Character result

Tipo de datos

text

Alias
UMLS CUI [1]
C2350015
CLINICAL CHEMISTRY - GnRH (GnRH)
Descripción

CLINICAL CHEMISTRY - GnRH (GnRH)

Alias
UMLS CUI-1
C2697516
Study part
Descripción

Study part

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
GnRH
Descripción

Gonadotropin Releasing Hormone Measurement

Tipo de datos

integer

Alias
UMLS CUI [1]
C2697516
If Numeric result, value:
Descripción

Numeric result

Tipo de datos

integer

Alias
UMLS CUI [1]
C2347373
If Character result, value:
Descripción

Character result

Tipo de datos

text

Alias
UMLS CUI [1]
C2350015
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Similar models

Clinical Chemistry Pitutary Coagulation GnRH

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
PITUITARY ADRENAL (PIT_ADREN)
C0428359 (UMLS CUI-1)
Item
Study part
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Study part
Code List
Study part
CL Item
Day 1 (Pre-dose) (Day 1 (Pre-dose))
CL Item
Day 14 (+24 hrs) (Day 14 (+24 hrs))
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Laboratory name address
Item
Laboratory name and address
text
C3258037 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Item
Laboratory name and address
integer
C3258037 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Laboratory name address
Code List
Laboratory name and address
CL Item
Results from the same lab as in the previous visit (98)
CL Item
When not, please provide laboratory name and address (99)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Item
Has the subject fasted?
text
C0015663 (UMLS CUI [1])
undefined item
Code List
Has the subject fasted?
CL Item
Yes (Y)
CL Item
No (N)
Item
Analysis
text
C0936012 (UMLS CUI [1])
undefined item
Code List
Analysis
CL Item
FSH (FSH)
C0202022 (UMLS CUI-1)
(Comment:en)
CL Item
Estradiol (Estradiol)
C0014912 (UMLS CUI-1)
(Comment:en)
CL Item
Testosterone, total (Testosterone, total)
C0202227 (UMLS CUI-1)
(Comment:en)
CL Item
Lutenizing Hormone (Lutenizing Hormone)
C1954318 (UMLS CUI-1)
(Comment:en)
CL Item
Prolactin (Prolactin)
C0373706 (UMLS CUI-1)
(Comment:en)
CL Item
TSH (TSH)
C0202230 (UMLS CUI-1)
(Comment:en)
CL Item
Thyroxine, total (Thyroxine, total)
C1281902 (UMLS CUI-1)
(Comment:en)
CL Item
Total T3 (Total T3)
C0428419 (UMLS CUI-1)
(Comment:en)
CL Item
ACTH Baseline (ACTH Baseline)
C2733242 (UMLS CUI-1)
(Comment:en)
CL Item
ACTH(+ 60 min) (ACTH(+ 60 min))
C0482460 (UMLS CUI-1)
(Comment:en)
Item
Result Type
integer
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
undefined item
Code List
Result Type
CL Item
Numeric result (97)
C2347373 (UMLS CUI-1)
(Comment:en)
CL Item
Character result (98)
C2350015 (UMLS CUI-1)
(Comment:en)
CL Item
No result (99)
C1274040 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
(Comment:en)
Numeric result
Item
If Numeric result, value:
integer
C2347373 (UMLS CUI [1])
Character result
Item
If Character result, value:
text
C2350015 (UMLS CUI [1])
Item
ACTH(+ 60 min) normal/ Abnormal?
integer
C0201835 (UMLS CUI [1])
undefined item
Code List
ACTH(+ 60 min) normal/ Abnormal?
CL Item
Normal (1)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal (2)
C0205161 (UMLS CUI-1)
(Comment:en)
Item Group
COAGULATION (COAG)
C1167912 (UMLS CUI-1)
Item
Study part
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Study part
Code List
Study part
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 3 (Day 3)
Item
Analysis
text
C0936012 (UMLS CUI [1])
undefined item
Code List
Analysis
CL Item
Partial Thromboplastin Time (Partial Thromboplastin Time)
C1531697 (UMLS CUI-1)
(Comment:en)
CL Item
Prothrombin Time (Prothrombin Time)
C0033707 (UMLS CUI-1)
(Comment:en)
CL Item
International Normalized Ratio (International Normalized Ratio)
C0525032 (UMLS CUI-1)
(Comment:en)
CL Item
R Value (R Value)
(Comment:en)
CL Item
K Value (K Value)
(Comment:en)
CL Item
Alpha Angle (Alpha Angle)
C2585389 (UMLS CUI-1)
(Comment:en)
CL Item
Maximum Amplitude (Maximum Amplitude)
C3263552 (UMLS CUI-1)
(Comment:en)
CL Item
D-Dimer (D-Dimer)
C2826333 (UMLS CUI-1)
(Comment:en)
CL Item
von Willebrand Factor (von Willebrand Factor)
C0042971 (UMLS CUI-1)
(Comment:en)
CL Item
Platelets (Platelets)
Item
Result Type
integer
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
undefined item
Code List
Result Type
CL Item
Numeric result (97)
C2347373 (UMLS CUI-1)
(Comment:en)
CL Item
Character result (98)
C2350015 (UMLS CUI-1)
(Comment:en)
CL Item
No result (99)
C1274040 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
(Comment:en)
Numeric result
Item
If Numeric result, value:
integer
C2347373 (UMLS CUI [1])
Character result
Item
If Character result, value:
text
C2350015 (UMLS CUI [1])
Item Group
CLINICAL CHEMISTRY - GnRH (GnRH)
C2697516 (UMLS CUI-1)
Item
Study part
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Study part
Code List
Study part
CL Item
Day 1 (Pre-dose) (Day 1 (Pre-dose))
CL Item
Day 14 (+24hrs) (Day 14 (+24hrs))
Item
GnRH
integer
C2697516 (UMLS CUI [1])
undefined item
Code List
GnRH
CL Item
Numeric result (97)
C2347373 (UMLS CUI-1)
(Comment:en)
CL Item
Character result (98)
C2350015 (UMLS CUI-1)
(Comment:en)
CL Item
No result (99)
C1274040 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
(Comment:en)
Numeric result
Item
If Numeric result, value:
integer
C2347373 (UMLS CUI [1])
Character result
Item
If Character result, value:
text
C2350015 (UMLS CUI [1])
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