ID

38757

Description

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Keywords

Versions (1)
  1. 11/1/19 11/1/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 1, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

English

Electronically Transferred Lab Data (Period 1 - 5; Day 1 - Day 16)

1 forms  
Electronically Transferred Lab Data (Day-1 Labs) (Period 1-5)
Description

Electronically Transferred Lab Data (Day-1 Labs) (Period 1-5)

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Haematology Date and time sample taken
Description

Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sample taken - not done
Description

Haematology sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Description

Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry sample same as the Haematology sample
Description

Clinical Chemistry sample same as the Haematology sample

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0018941
Clinical Chemistry sample taken - not done
Description

Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data (Day-1 Labs (steroid hormone test)) (Period 1-5)
Description

Electronically Transferred Lab Data (Day-1 Labs (steroid hormone test)) (Period 1-5)

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
UMLS CUI-3
C0301818
Clinical Chemistry Date and time sample taken
Description

Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry sample taken - not done
Description

Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
Urinalysis Date and Time sample taken
Description

Urinalysis Date and Time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis sample taken - not done
Description

Urinalysis sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data (Lab)
Description

Electronically Transferred Lab Data (Lab)

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Dosing date/time
Description

Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
12 hrs - Haematology Date and time sample taken
Description

12 hrs - Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
12 hrs - Haematology sample taken - not done
Description

12 hrs - Haematology sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
12 hrs - Clinical Chemistry Date and time sample taken
Description

12 hrs - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
12 hrs - Clinical Chemistry sample same as the Haematology sample
Description

12 hrs - Clinical Chemistry sample same as the Haematology sample

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0018941
12 hrs - Clinical Chemistry sample taken - not done
Description

12 hrs - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
24 hrs - Haematology Date and time sample taken
Description

24 hrs - Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
24 hrs - Haematology sample taken - not done
Description

24 hrs - Haematology sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
24 hrs - Clinical Chemistry Date and time sample taken
Description

24 hrs - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
24 hrs - Clinical Chemistry sample same as the Haematology sample
Description

24 hrs - Clinical Chemistry sample same as the Haematology sample

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0018941
24 hrs - Clinical Chemistry sample taken - not done
Description

24 hrs - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data (Lab (steroid hormone test)) (Period 1-5)
Description

Electronically Transferred Lab Data (Lab (steroid hormone test)) (Period 1-5)

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
UMLS CUI-3
C0301818
Dosing date/time
Description

Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
24 hrs - Clinical Chemistry Date and time sample taken
Description

24 hrs - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
24 hrs - Clinical Chemistry sample taken - not done
Description

24 hrs - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
24 hrs - Urinalysis Date and Time sample taken
Description

24 hrs - Urinalysis Date and Time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
24 hrs - Urinalysis sample taken - not done
Description

24 hrs - Urinalysis sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data (Lab) (Day 1 - 13)
Description

Electronically Transferred Lab Data (Lab) (Day 1 - 13)

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
AM Dosing date/time
Description

AM Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C4331833
PM Dosing date/time
Description

PM Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1509133
12 hrs - Haematology Date and time sample taken
Description

12 hrs - Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
12 hrs - Haematology sample taken - not done
Description

12 hrs - Haematology sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
12 hrs - Clinical Chemistry Date and time sample taken
Description

12 hrs - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
12 hrs - Clinical Chemistry sample taken - not done
Description

12 hrs - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
24 hrs - Haematology Date and time sample taken
Description

24 hrs - Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
24 hrs - Haematology sample taken - not done
Description

24 hrs - Haematology sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
24 hrs - Clinical Chemistry Date and time sample taken
Description

24 hrs - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
24 hrs - Clinical Chemistry sample taken - not done
Description

24 hrs - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
Electronicallly Transferred Lab Data (Lab (steroid hormone test)) (Day 1 - 13)
Description

Electronicallly Transferred Lab Data (Lab (steroid hormone test)) (Day 1 - 13)

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
PM Dosing date/time
Description

PM Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1509133
36 hrs - Clinical Chemistry Date and time sample taken
Description

36 hrs - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
36 hrs - Clinical Chemistry sample taken - not done
Description

36 hrs - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
36 hrs - Urinalysis Date and Time sample taken
Description

36 hrs - Urinalysis Date and Time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
36 hrs - Urinalysis sample taken - not done
Description

36 hrs - Urinalysis sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data (Lab) (Day 14 - 16)
Description

Electronically Transferred Lab Data (Lab) (Day 14 - 16)

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
AM Dosing date/time
Description

AM Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C4331833
PM Dosing date/time
Description

PM Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1509133
Pre dose - Haematology Date and time sample taken
Description

Pre dose - Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
UMLS CUI [1,5]
C0439565
Pre dose - Haematology sample taken - not done
Description

Pre dose - Haematology sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C0439565
Pre dose - Clinical Chemistry Date and time sample taken
Description

Pre dose - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
UMLS CUI [1,5]
C0439565
Pre Dose - Clinical Chemistry sample same as the Haematology sample
Description

Pre Dose - Clinical Chemistry sample same as the Haematology sample

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0018941
UMLS CUI [1,4]
C0439565
Pre dose - Clinical Chemistry sample taken - not done
Description

Pre dose - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C0439565
12 hrs - Haematology Date and time sample taken
Description

12 hrs - Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
12 hrs - Haematology sample taken - not done
Description

12 hrs - Haematology sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
12 hrs - Clinical Chemistry Date and time sample taken
Description

12 hrs - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
12 hrs - Clinical Chemistry sample same as the Haematology sample
Description

12 hrs - Clinical Chemistry sample same as the Haematology sample

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0018941
12 hrs - Clinical Chemistry sample taken - not done
Description

12 hrs - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
24 hrs - Haematology Date and time sample taken
Description

24 hrs - Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
24 hrs - Haematology sample taken - not done
Description

24 hrs - Haematology sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
24 hrs - Clinical Chemistry Date and time sample taken
Description

24 hrs - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
24 hrs - Clinical Chemistry sample same as the Haematology sample
Description

24 hrs - Clinical Chemistry sample same as the Haematology sample

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0018941
24 hrs - Clinical Chemistry sample taken - not done
Description

24 hrs - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data (Lab (steroid hormone test)) (Day 14 - 16)
Description

Electronically Transferred Lab Data (Lab (steroid hormone test)) (Day 14 - 16)

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
AM Dosing date/time
Description

AM Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C4331833
PM Dosing date/time
Description

PM Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1509133
Pre dose - Clinical Chemistry Date and time sample taken
Description

Pre dose - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
UMLS CUI [1,5]
C0439565
Pre dose - Clinical Chemistry sample taken - not done
Description

Pre dose - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C0439565
Pre dose - Urinalysis Date and Time sample taken
Description

Pre dose - Urinalysis Date and Time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
UMLS CUI [1,4]
C0439565
Pre dose - Urinalysis sample taken - not done
Description

Pre dose - Urinalysis sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C0439565
60 hrs - Clinical Chemistry Date and time sample taken
Description

60 hrs - Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
60 hrs - Clinical Chemistry sample taken - not done
Description

60 hrs - Clinical Chemistry sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1272696
60 hrs - Urinalysis Date and Time sample taken
Description

60 hrs - Urinalysis Date and Time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
60 hrs - Urinalysis sample taken - not done
Description

60 hrs - Urinalysis sample taken - not done

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
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Similar models

Electronically Transferred Lab Data (Period 1 - 5; Day 1 - Day 16)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Electronically Transferred Lab Data (Day-1 Labs) (Period 1-5)
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sample taken - not done
text
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Haematology sample taken - not done
Code List
Haematology sample taken - not done
CL Item
Not Done (ND)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Clinical Chemistry sample same as the Haematology sample
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Clinical Chemistry sample same as the Haematology sample
Code List
Clinical Chemistry sample same as the Haematology sample
CL Item
Same as the Haematology sample (98)
Item
Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Clinical Chemistry sample taken - not done
Code List
Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
Item Group
Electronically Transferred Lab Data (Day-1 Labs (steroid hormone test)) (Period 1-5)
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
C0301818 (UMLS CUI-3)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Clinical Chemistry sample taken - not done
Code List
Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
Urinalysis Date and Time sample taken
Item
Urinalysis Date and Time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinalysis sample taken - not done
text
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis sample taken - not done
Code List
Urinalysis sample taken - not done
CL Item
Not Done (ND)
Item Group
Electronically Transferred Lab Data (Lab)
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
12 hrs - Haematology Date and time sample taken
Item
12 hrs - Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
12 hrs - Haematology sample taken - not done
text
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
12 hrs - Haematology sample taken - not done
Code List
12 hrs - Haematology sample taken - not done
CL Item
Not Done (ND)
12 hrs - Clinical Chemistry Date and time sample taken
Item
12 hrs - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
12 hrs - Clinical Chemistry sample same as the Haematology sample
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
12 hrs - Clinical Chemistry sample same as the Haematology sample
Code List
12 hrs - Clinical Chemistry sample same as the Haematology sample
CL Item
Same as the Haematology sample (98)
Item
12 hrs - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
12 hrs - Clinical Chemistry sample taken - not done
Code List
12 hrs - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
24 hrs - Haematology Date and time sample taken
Item
24 hrs - Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
24 hrs - Haematology sample taken - not done
text
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
24 hrs - Haematology sample taken - not done
Code List
24 hrs - Haematology sample taken - not done
CL Item
Not Done (ND)
24 hrs - Clinical Chemistry Date and time sample taken
Item
24 hrs - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
24 hrs - Clinical Chemistry sample same as the Haematology sample
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
24 hrs - Clinical Chemistry sample same as the Haematology sample
Code List
24 hrs - Clinical Chemistry sample same as the Haematology sample
CL Item
Same as the Haematology sample (98)
Item
24 hrs - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
24 hrs - Clinical Chemistry sample taken - not done
Code List
24 hrs - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
Item Group
Electronically Transferred Lab Data (Lab (steroid hormone test)) (Period 1-5)
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
C0301818 (UMLS CUI-3)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
24 hrs - Clinical Chemistry Date and time sample taken
Item
24 hrs - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
24 hrs - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Clinical Chemistry sample taken - not done
Code List
24 hrs - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
24 hrs - Urinalysis Date and Time sample taken
Item
24 hrs - Urinalysis Date and Time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
24 hrs - Urinalysis sample taken - not done
text
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis sample taken - not done
Code List
24 hrs - Urinalysis sample taken - not done
CL Item
Not Done (ND)
Item Group
Electronically Transferred Lab Data (Lab) (Day 1 - 13)
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
AM Dosing date/time
Item
AM Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C4331833 (UMLS CUI [1,4])
PM Dosing date/time
Item
PM Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1509133 (UMLS CUI [1,4])
12 hrs - Haematology Date and time sample taken
Item
12 hrs - Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
12 hrs - Haematology sample taken - not done
text
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
12 hrs - Haematology sample taken - not done
Code List
12 hrs - Haematology sample taken - not done
CL Item
Not Done (ND)
12 hrs - Clinical Chemistry Date and time sample taken
Item
12 hrs - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
12 hrs - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
12 hrs - Clinical Chemistry sample taken - not done
Code List
12 hrs - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
24 hrs - Haematology Date and time sample taken
Item
24 hrs - Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
24 hrs - Haematology sample taken - not done
text
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
24 hrs - Haematology sample taken - not done
Code List
24 hrs - Haematology sample taken - not done
CL Item
Not Done (ND)
24 hrs - Clinical Chemistry Date and time sample taken
Item
24 hrs - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
24 hrs - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
24 hrs - Clinical Chemistry sample taken - not done
Code List
24 hrs - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
Item Group
Electronicallly Transferred Lab Data (Lab (steroid hormone test)) (Day 1 - 13)
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
PM Dosing date/time
Item
PM Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1509133 (UMLS CUI [1,4])
36 hrs - Clinical Chemistry Date and time sample taken
Item
36 hrs - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
36 hrs - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
36 hrs - Clinical Chemistry sample taken - not done
Code List
36 hrs - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
36 hrs - Urinalysis Date and Time sample taken
Item
36 hrs - Urinalysis Date and Time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
36 hrs - Urinalysis sample taken - not done
text
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
36 hrs - Urinalysis sample taken - not done
Code List
36 hrs - Urinalysis sample taken - not done
CL Item
Not Done (ND)
Item Group
Electronically Transferred Lab Data (Lab) (Day 14 - 16)
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
AM Dosing date/time
Item
AM Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C4331833 (UMLS CUI [1,4])
PM Dosing date/time
Item
PM Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1509133 (UMLS CUI [1,4])
Pre dose - Haematology Date and time sample taken
Item
Pre dose - Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0439565 (UMLS CUI [1,5])
Item
Pre dose - Haematology sample taken - not done
text
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Pre dose - Haematology sample taken - not done
Code List
Pre dose - Haematology sample taken - not done
CL Item
Not Done (ND)
Pre dose - Clinical Chemistry Date and time sample taken
Item
Pre dose - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0439565 (UMLS CUI [1,5])
Item
Pre Dose - Clinical Chemistry sample same as the Haematology sample
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Pre Dose - Clinical Chemistry sample same as the Haematology sample
Code List
Pre Dose - Clinical Chemistry sample same as the Haematology sample
CL Item
Same as the Haematology sample (98)
Item
Pre dose - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Pre dose - Clinical Chemistry sample taken - not done
Code List
Pre dose - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
12 hrs - Haematology Date and time sample taken
Item
12 hrs - Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
12 hrs - Haematology sample taken - not done
text
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
12 hrs - Clinical Chemistry sample taken - not done
Code List
12 hrs - Haematology sample taken - not done
CL Item
Not Done (ND)
12 hrs - Clinical Chemistry Date and time sample taken
Item
12 hrs - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
12 hrs - Clinical Chemistry sample same as the Haematology sample
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
12 hrs - Clinical Chemistry sample same as the Haematology sample
Code List
12 hrs - Clinical Chemistry sample same as the Haematology sample
CL Item
Same as the Haematology sample (98)
Item
12 hrs - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
12 hrs - Clinical Chemistry sample taken - not done
Code List
12 hrs - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
24 hrs - Haematology Date and time sample taken
Item
24 hrs - Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
24 hrs - Haematology sample taken - not done
text
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
24 hrs - Haematology sample taken - not done
Code List
24 hrs - Haematology sample taken - not done
CL Item
Not Done (ND)
24 hrs - Clinical Chemistry Date and time sample taken
Item
24 hrs - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
24 hrs - Clinical Chemistry sample same as the Haematology sample
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
24 hrs - Clinical Chemistry sample same as the Haematology sample
Code List
24 hrs - Clinical Chemistry sample same as the Haematology sample
CL Item
Same as the Haematology sample (98)
Item
24 hrs - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
24 hrs - Clinical Chemistry sample taken - not done
Code List
24 hrs - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
Item Group
Electronically Transferred Lab Data (Lab (steroid hormone test)) (Day 14 - 16)
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
AM Dosing date/time
Item
AM Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C4331833 (UMLS CUI [1,4])
PM Dosing date/time
Item
PM Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1509133 (UMLS CUI [1,4])
Pre dose - Clinical Chemistry Date and time sample taken
Item
Pre dose - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0439565 (UMLS CUI [1,5])
Item
Pre dose - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Pre dose - Clinical Chemistry sample taken - not done
Code List
Pre dose - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
Pre dose - Urinalysis Date and Time sample taken
Item
Pre dose - Urinalysis Date and Time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Item
Pre dose - Urinalysis sample taken - not done
text
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Pre dose - Urinalysis sample taken - not done
Code List
Pre dose - Urinalysis sample taken - not done
CL Item
Not Done (ND)
60 hrs - Clinical Chemistry Date and time sample taken
Item
60 hrs - Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
60 hrs - Clinical Chemistry sample taken - not done
text
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
60 hrs - Clinical Chemistry sample taken - not done
Code List
60 hrs - Clinical Chemistry sample taken - not done
CL Item
Not Done (ND)
60 hrs - Urinalysis Date and Time sample taken
Item
60 hrs - Urinalysis Date and Time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
60 hrs - Urinalysis sample taken - not done
text
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
60 hrs - Urinalysis sample taken - not done
Code List
60 hrs - Urinalysis sample taken - not done
CL Item
Not Done (ND)
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