ID

30583

Beskrivning

Study part: Urinalysis-Local, Protein, Pooled. 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.

Nyckelord

Versioner (1)
  1. 2018-06-16 2018-06-16 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

16 juni 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Urinalysis Local Protein Pooled Pazopanib Macular Degeneration MD1103367

Engelsk

Urinalysis

1 Formulär  
  1. StudyEvent: ODM
    1. Urinalysis
URINALYSIS - LOCAL SCREENING
Beskrivning

URINALYSIS - LOCAL SCREENING

Alias
UMLS CUI-1
C0042014
Study part
Beskrivning

Study part

Datatyp

text

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

Laboratory ID

Datatyp

text

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

Laboratory name address

Datatyp

integer

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

Laboratory name address

Datatyp

text

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

Date and time sample taken

Datatyp

datetime

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

Fasting

Datatyp

text

Alias
UMLS CUI [1]
C0015663
Analysis
Beskrivning

Analysis

Datatyp

text

Alias
UMLS CUI [1]
C0936012
Result Type
Beskrivning

Result Type

Datatyp

integer

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

Numeric result

Datatyp

integer

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

Character result

Datatyp

text

Alias
UMLS CUI [1]
C2350015
Result of dipstick
Beskrivning

Result of dipstick

Datatyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Was sedimentary microscopy performed?
Beskrivning

sedimentary microscopy

Datatyp

text

Alias
UMLS CUI [1]
C0430397
URINALYSIS- SPOT PROTEIN
Beskrivning

URINALYSIS- SPOT PROTEIN

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0033684
Study part
Beskrivning

Study part

Datatyp

text

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

Analysis

Datatyp

text

Alias
UMLS CUI [1]
C0936012
Result Type
Beskrivning

Result Type

Datatyp

integer

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

Numeric result

Datatyp

integer

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

Character result

Datatyp

text

Alias
UMLS CUI [1]
C2350015
URINALYSIS- POOLED
Beskrivning

URINALYSIS- POOLED

Alias
UMLS CUI-1
C0042014
Study part
Beskrivning

Study part

Datatyp

text

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

Analysis

Datatyp

text

Alias
UMLS CUI [1]
C0936012
Result Type
Beskrivning

Result Type

Datatyp

integer

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

Numeric result

Datatyp

integer

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

Character result

Datatyp

text

Alias
UMLS CUI [1]
C2350015
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Similar models

Urinalysis

1 Formulär
  1. StudyEvent: ODM
    1. Urinalysis
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
URINALYSIS - LOCAL SCREENING
C0042014 (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
Pre-treatment (Pre-treatment)
CL Item
Days 4 (Days 4)
CL Item
Days 7 (Days 7)
CL Item
Days 10 (pre-dose) (Days 10 (pre-dose))
CL Item
Day 14 at +24 hr (Day 14 at +24 hr)
CL Item
Follow-up (Follow-up)
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
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
Please provide name and address, when (99)
Laboratory name address
Item
Laboratory name and address
text
C3258037 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
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
pH (pH)
C0042044 (UMLS CUI-1)
(Comment:en)
CL Item
Specific Gravity (Specific Gravity)
C0202517 (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
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
undefined item
Code List
Result of dipstick
CL Item
No result  (NR)
C1274040 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
(Comment:en)
CL Item
Negative  (NEG)
C0205160 (UMLS CUI-1)
(Comment:en)
CL Item
Positive, provide details on the DIPSTICK form. (POS)
C0430370 (UMLS CUI-1)
C1446409 (UMLS CUI-2)
(Comment:en)
Item
Was sedimentary microscopy performed?
text
C0430397 (UMLS CUI [1])
undefined item
Code List
Was sedimentary microscopy performed?
CL Item
No (N)
CL Item
Yes, provide details on the MICROSCOPY form (Y)
Item Group
URINALYSIS- SPOT PROTEIN
C0042014 (UMLS CUI-1)
C0033684 (UMLS CUI-2)
Item
Study part
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Study part
Code List
Study part
CL Item
Days 2- 13 (Days 2- 13)
CL Item
Days 15 (Days 15)
CL Item
Follow-up (Follow-up)
Item
Analysis
text
C0936012 (UMLS CUI [1])
undefined item
Code List
Analysis
CL Item
Albumin/Creatinine ratio (Albumin/Creatinine ratio)
C0455271 (UMLS CUI-1)
(Comment:en)
CL Item
Albumin (Albumin)
C0042038 (UMLS CUI-1)
(Comment:en)
CL Item
Creatinine (Creatinine)
C0428283 (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 Group
URINALYSIS- POOLED
C0042014 (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 2 (Day 2)
Item
Analysis
text
C0936012 (UMLS CUI [1])
Analysis
Code List
Analysis
CL Item
pH (pH)
C0042044 (UMLS CUI-1)
(Comment:en)
CL Item
Volume (Volume)
C2700258 (UMLS CUI-1)
(Comment:en)
CL Item
Albumin/Creatinine ratio (Albumin/Creatinine ratio)
C0455271 (UMLS CUI-1)
(Comment:en)
CL Item
Albumin Excretion Rate (Albumin Excretion Rate)
C0585937 (UMLS CUI-1)
(Comment:en)
CL Item
Creatinine (Creatinine)
C0428283 (UMLS CUI-1)
(Comment:en)
CL Item
Sodium (Sodium)
C0337444 (UMLS CUI-1)
(Comment:en)
CL Item
Chloride (Chloride)
C0201953 (UMLS CUI-1)
(Comment:en)
CL Item
Urea (Urea)
C0428278 (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])
Tillbaka till toppen 

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