ID

38757

Descrizione

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

  1. 01/11/19 01/11/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

1 novembre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

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

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

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

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
Descrizione

Haematology Date and time sample taken

Tipo di dati

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
Descrizione

Haematology sample taken - not done

Tipo di dati

text

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

Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

Clinical Chemistry sample same as the Haematology sample

Tipo di dati

text

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

Clinical Chemistry sample taken - not done

Tipo di dati

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)
Descrizione

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
Descrizione

Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

Clinical Chemistry sample taken - not done

Tipo di dati

text

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

Urinalysis Date and Time sample taken

Tipo di dati

datetime

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

Urinalysis sample taken - not done

Tipo di dati

text

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

Electronically Transferred Lab Data (Lab)

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

Dosing date/time

Tipo di dati

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
Descrizione

12 hrs - Haematology Date and time sample taken

Tipo di dati

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
Descrizione

12 hrs - Haematology sample taken - not done

Tipo di dati

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
Descrizione

12 hrs - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

12 hrs - Clinical Chemistry sample same as the Haematology sample

Tipo di dati

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
Descrizione

12 hrs - Clinical Chemistry sample taken - not done

Tipo di dati

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
Descrizione

24 hrs - Haematology Date and time sample taken

Tipo di dati

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
Descrizione

24 hrs - Haematology sample taken - not done

Tipo di dati

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
Descrizione

24 hrs - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

24 hrs - Clinical Chemistry sample same as the Haematology sample

Tipo di dati

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
Descrizione

24 hrs - Clinical Chemistry sample taken - not done

Tipo di dati

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)
Descrizione

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
Descrizione

Dosing date/time

Tipo di dati

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
Descrizione

24 hrs - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

24 hrs - Clinical Chemistry sample taken - not done

Tipo di dati

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
Descrizione

24 hrs - Urinalysis Date and Time sample taken

Tipo di dati

datetime

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

24 hrs - Urinalysis sample taken - not done

Tipo di dati

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)
Descrizione

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

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

AM Dosing date/time

Tipo di dati

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
Descrizione

PM Dosing date/time

Tipo di dati

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
Descrizione

12 hrs - Haematology Date and time sample taken

Tipo di dati

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
Descrizione

12 hrs - Haematology sample taken - not done

Tipo di dati

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
Descrizione

12 hrs - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

12 hrs - Clinical Chemistry sample taken - not done

Tipo di dati

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
Descrizione

24 hrs - Haematology Date and time sample taken

Tipo di dati

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
Descrizione

24 hrs - Haematology sample taken - not done

Tipo di dati

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
Descrizione

24 hrs - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

24 hrs - Clinical Chemistry sample taken - not done

Tipo di dati

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)
Descrizione

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

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

PM Dosing date/time

Tipo di dati

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
Descrizione

36 hrs - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

36 hrs - Clinical Chemistry sample taken - not done

Tipo di dati

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
Descrizione

36 hrs - Urinalysis Date and Time sample taken

Tipo di dati

datetime

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

36 hrs - Urinalysis sample taken - not done

Tipo di dati

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)
Descrizione

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

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

AM Dosing date/time

Tipo di dati

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
Descrizione

PM Dosing date/time

Tipo di dati

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
Descrizione

Pre dose - Haematology Date and time sample taken

Tipo di dati

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
Descrizione

Pre dose - Haematology sample taken - not done

Tipo di dati

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
Descrizione

Pre dose - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

Pre Dose - Clinical Chemistry sample same as the Haematology sample

Tipo di dati

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
Descrizione

Pre dose - Clinical Chemistry sample taken - not done

Tipo di dati

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
Descrizione

12 hrs - Haematology Date and time sample taken

Tipo di dati

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
Descrizione

12 hrs - Haematology sample taken - not done

Tipo di dati

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
Descrizione

12 hrs - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

12 hrs - Clinical Chemistry sample same as the Haematology sample

Tipo di dati

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
Descrizione

12 hrs - Clinical Chemistry sample taken - not done

Tipo di dati

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
Descrizione

24 hrs - Haematology Date and time sample taken

Tipo di dati

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
Descrizione

24 hrs - Haematology sample taken - not done

Tipo di dati

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
Descrizione

24 hrs - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

24 hrs - Clinical Chemistry sample same as the Haematology sample

Tipo di dati

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
Descrizione

24 hrs - Clinical Chemistry sample taken - not done

Tipo di dati

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)
Descrizione

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

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

AM Dosing date/time

Tipo di dati

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
Descrizione

PM Dosing date/time

Tipo di dati

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
Descrizione

Pre dose - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

Pre dose - Clinical Chemistry sample taken - not done

Tipo di dati

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
Descrizione

Pre dose - Urinalysis Date and Time sample taken

Tipo di dati

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
Descrizione

Pre dose - Urinalysis sample taken - not done

Tipo di dati

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
Descrizione

60 hrs - Clinical Chemistry Date and time sample taken

Tipo di dati

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
Descrizione

60 hrs - Clinical Chemistry sample taken - not done

Tipo di dati

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
Descrizione

60 hrs - Urinalysis Date and Time sample taken

Tipo di dati

datetime

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

60 hrs - Urinalysis sample taken - not done

Tipo di dati

text

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

Similar models

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

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
Code List
60 hrs - Urinalysis sample taken - not done
CL Item
Not Done (ND)

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