ID

38811

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

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

English

12-Lead ECG (Period 1 -5; Day 1 - Day 13)

1 forms  
12-Lead ECG (Period 1 - 5) - Dosing date/time
Description

12-Lead ECG (Period 1 - 5) - Dosing date/time

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
Dosing date/time
Description

Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
12-Lead ECG (Period 1 - 5)
Description

12-Lead ECG (Period 1 - 5)

Alias
UMLS CUI-1
C0430456
Timepoint of ECG
Description

Timepoint of ECG

Data type

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0430456
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Description

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTcB Interval
Description

QTcB Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
ms
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG (Day 1 - 13) - Dose
Description

12-Lead ECG (Day 1 - 13) - Dose

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0178602
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
12-Lead ECG (Day 1 - 13)
Description

12-Lead ECG (Day 1 - 13)

Alias
UMLS CUI-1
C0430456
Timepont of ECG
Description

Timepont of ECG

Data type

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0430456
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Description

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTcB Interval
Description

QTcB Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
ms
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Back to the top of the page

Similar models

12-Lead ECG (Period 1 -5; Day 1 - Day 13)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12-Lead ECG (Period 1 - 5) - Dosing date/time
C0430456 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
12-Lead ECG (Period 1 - 5)
C0430456 (UMLS CUI-1)
Item
Timepoint of ECG
integer
C2348792 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Timepoint of ECG
Code List
Timepoint of ECG
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
8 hr (8)
CL Item
12 hr (9)
CL Item
24 hr (10)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
integer
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (2)
CL Item
No result (not available) (3)
Item Group
12-Lead ECG (Day 1 - 13) - Dose
C0430456 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
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
12-Lead ECG (Day 1 - 13)
C0430456 (UMLS CUI-1)
Item
Timepont of ECG
integer
C2348792 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Timepont of ECG
Code List
Timepont of ECG
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 option (11)
CL Item
20 hr / not done option (12)
CL Item
24 hr (Day 2) (13)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
integer
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (2)
CL Item
No result (not available) (3)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial