ID

30541

Beschrijving

Study part: Urinalysis. 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.

Trefwoorden

Versies (1)
  1. 12-06-18 12-06-18 -
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GlaxoSmithKline

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12 juni 2018

DOI

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Creative Commons BY-NC 3.0
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Urinalysis Pazopanib Macular Degeneration MD1103367

Engels

Urinalysis

1 Formulieren  
  1. StudyEvent: ODM
    1. Urinalysis
URINALYSIS - LOCAL SCREENING
Beschrijving

URINALYSIS - LOCAL SCREENING

Alias
UMLS CUI-1
C0042014
Laboratory ID
Beschrijving

Laboratory ID

Datatype

text

Alias
UMLS CUI [1]
C2986056
Laboratory name
Beschrijving

Laboratory name

Datatype

text

Alias
UMLS CUI [1]
C3258037
Address
Beschrijving

Address

Datatype

text

Alias
UMLS CUI [1]
C1442065
Date and time sample taken
Beschrijving

Date and time sample taken

Datatype

datetime

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

Fasting

Datatype

text

Alias
UMLS CUI [1]
C0015663
Analysis
Beschrijving

Analysis

Datatype

text

Alias
UMLS CUI [1]
C0936012
Result Type
Beschrijving

Result Type

Datatype

integer

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

Numeric result

Datatype

integer

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

Character result

Datatype

text

Alias
UMLS CUI [1]
C2350015
Result of dipstick
Beschrijving

Result of dipstick

Datatype

text

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

sedimentary microscopy

Datatype

text

Alias
UMLS CUI [1]
C0430397
URINALYSIS - LOCAL: DIPSTICK DETAILS
Beschrijving

URINALYSIS - LOCAL: DIPSTICK DETAILS

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
Study part:
Beschrijving

Study part

Datatype

text

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

Analysis

Datatype

text

Alias
UMLS CUI [1]
C0936012
Result Type
Beschrijving

Result Type

Datatype

integer

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

Numeric result

Datatype

integer

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

Character result

Datatype

text

Alias
UMLS CUI [1]
C2350015
URINALYSIS- LOCAL: MICROSCOPY DETAILS
Beschrijving

URINALYSIS- LOCAL: MICROSCOPY DETAILS

Alias
UMLS CUI-1
C0430397
Study part:
Beschrijving

Study part

Datatype

text

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

Analysis

Datatype

text

Alias
UMLS CUI [1]
C0936012
Result Type
Beschrijving

Result Type

Datatype

integer

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

Numeric result

Datatype

integer

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

Character result

Datatype

text

Alias
UMLS CUI [1]
C2350015
URINALYSIS - PROTEIN- SCREENING
Beschrijving

URINALYSIS - PROTEIN- SCREENING

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0033684
Analysis
Beschrijving

Analysis

Datatype

text

Alias
UMLS CUI [1]
C0936012
Result Type
Beschrijving

Result Type

Datatype

integer

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

Numeric result

Datatype

integer

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

Character result

Datatype

text

Alias
UMLS CUI [1]
C2350015
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Similar models

Urinalysis

1 Formulieren
  1. StudyEvent: ODM
    1. Urinalysis
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
URINALYSIS - LOCAL SCREENING
C0042014 (UMLS CUI-1)
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1])
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 - LOCAL: DIPSTICK DETAILS
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
Item
Study part:
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
undefined item
Code List
Study part:
CL Item
Screening (Screening)
C0220908 (UMLS CUI-1)
(Comment:en)
CL Item
Pre-treatment (Pre-treatment)
C2709094 (UMLS CUI-1)
(Comment:en)
CL Item
Days 4 (Days 4)
(Comment:en)
CL Item
Days 7 (Days 7)
(Comment:en)
CL Item
Days 10 (Pre-dose) (Days 10 (Pre-dose))
(Comment:en)
CL Item
Day 14 (+24 hrs) (Day 14 (+24 hrs))
(Comment:en)
CL Item
Follow-up (Follow-up)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Analysis
text
C0936012 (UMLS CUI [1])
undefined item
Code List
Analysis
CL Item
Protein (Protein)
C0262923 (UMLS CUI-1)
(Comment:en)
CL Item
Glucose (Glucose)
C0004076 (UMLS CUI-1)
(Comment:en)
CL Item
Ketones (Ketones)
C1991100 (UMLS CUI-1)
(Comment:en)
CL Item
Blood (Blood)
C0018965 (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- LOCAL: MICROSCOPY DETAILS
C0430397 (UMLS CUI-1)
Item
Study part:
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
undefined item
Code List
Study part:
CL Item
Screening (Screening)
C0220908 (UMLS CUI-1)
(Comment:en)
CL Item
Pre-treatment (Pre-treatment)
C2709094 (UMLS CUI-1)
(Comment:en)
CL Item
Days 4 (Days 4)
(Comment:en)
CL Item
Days 7 (Days 7)
(Comment:en)
CL Item
Days 10 (Pre-dose) (Days 10 (Pre-dose))
(Comment:en)
CL Item
Day 14 (+24 hrs) (Day 14 (+24 hrs))
(Comment:en)
CL Item
Follow-up (Follow-up)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Analysis
text
C0936012 (UMLS CUI [1])
undefined item
Code List
Analysis
CL Item
Red blood cells (Red blood cells)
C2188659 (UMLS CUI-1)
(Comment:en)
CL Item
White blood cells (White blood cells)
C0919738 (UMLS CUI-1)
C0026018 (UMLS CUI-2)
(Comment:en)
CL Item
Casts (Casts)
C4048266 (UMLS CUI-1)
C0430397 (UMLS CUI-2)
(Comment:en)
CL Item
Crystals (Crystals)
C1287304 (UMLS CUI-1)
(Comment:en)
CL Item
Epithelial cells (Epithelial cells)
C1318314 (UMLS CUI-1)
(Comment:en)
CL Item
Bacteria (Bacteria)
C1262012 (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 - PROTEIN- SCREENING
C0042014 (UMLS CUI-1)
C0033684 (UMLS CUI-2)
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)
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])
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