ID

38812

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. 11/5/19 11/5/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 5, 2019

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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

Vital Signs (Period 1 - 5; Day 1 - Day 13)

1 forms  
Vital Signs (Period 1 - 5) - Dosing date/ time
Description

Vital Signs (Period 1 - 5) - Dosing date/ time

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
Vital Signs (Period 1 - 5) - Dosing date/ time
Description

Vital Signs (Period 1 - 5) - Dosing date/ time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Vital Signs (Period 1 -5)
Description

Vital Signs (Period 1 -5)

Alias
UMLS CUI-1
C0518766
Vital Signs - Timepoint
Description

Vital Signs - Timepoint

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual date/ time
Description

Actual date/ time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Systolic Blood pressure
Description

Systolic Blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood pressure
Description

Diastolic Blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Vital Signs (Day 1 - 13) - Dosing date/ time
Description

Vital Signs (Day 1 - 13) - Dosing date/ time

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
AM Dosing date/ time
Description

AM Dosing date/ time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C4331833
PM Dosing date/ time
Description

PM Dosing date/ time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C1509133
Vital Signs (Day 1 - 13)
Description

Vital Signs (Day 1 - 13)

Alias
UMLS CUI-1
C0518766
Vital Signs - Timepoint
Description

Vital Signs - Timepoint

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual date/ time
Description

Actual date/ time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Systolic Blood pressure
Description

Systolic Blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood pressure
Description

Diastolic Blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
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Similar models

Vital Signs (Period 1 - 5; Day 1 - Day 13)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vital Signs (Period 1 - 5) - Dosing date/ time
C0518766 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
Vital Signs (Period 1 - 5) - Dosing date/ time
Item
Vital Signs (Period 1 - 5) - Dosing date/ time
datetime
C0518766 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Vital Signs (Period 1 -5)
C0518766 (UMLS CUI-1)
Item
Vital Signs - Timepoint
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs - Timepoint
Code List
Vital Signs - Timepoint
CL Item
Pre dose 1 (1)
CL Item
Pre dose 2 (2)
CL Item
Pre dose 3 (3)
CL Item
30 mins (4)
CL Item
1 hr (5)
CL Item
2 hr (6)
CL Item
4 hr (7)
CL Item
6 hr (8)
CL Item
8 hr (9)
CL Item
12 hr (10)
CL Item
24 hr (11)
Actual date/ time
Item
Actual date/ time
datetime
C1264639 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Vital Signs (Day 1 - 13) - Dosing date/ time
C0518766 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
AM Dosing date/ time
Item
AM Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
PM Dosing date/ time
Item
PM Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
Item Group
Vital Signs (Day 1 - 13)
C0518766 (UMLS CUI-1)
Item
Vital Signs - Timepoint
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs - Timepoint
Code List
Vital Signs - Timepoint
CL Item
Pre dose 1 (1)
CL Item
Pre dose 2 (2)
CL Item
Pre dose 3 (3)
CL Item
30 mins (4)
CL Item
2 hr (5)
CL Item
4 hr (6)
CL Item
8 hr (7)
CL Item
12 hr (8)
CL Item
12 hr:30 mins (9)
CL Item
14 hr (10)
CL Item
16 hr/ not done (11)
CL Item
20 hr/ not done (12)
CL Item
24 hr (13)
Actual date/ time
Item
Actual date/ time
datetime
C1264639 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
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