ID
38652
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)
- 10/29/19 10/29/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 29, 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.
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
Logs/ Repeats - 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood; Repeat Visual Analogue Scale; Repeat Nasal Endoscopy; Repeat Visual Nasal Examination
Description
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Description
Date and Time of ECG
Data type
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
(check all that apply)
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0199556
Description
If other abnormal rhythm, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C0947611
Description
(check all that apply)
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C2216025
Description
If other P-Wave Morphology, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
(check all that apply)
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0232217
Description
If other conduction, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
(check all that apply)
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0027051
Description
If other myocardial infarction, enter comment.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
(check all that apply)
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2,1]
- C1331539
- UMLS CUI [2,2]
- C0948857
Description
If other depololarisation/repolarisation, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Description
If other abnormalities, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
Repeat Pharmacokinetics Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
- UMLS CUI-3
- C0205341
Description
Repeat Visual Analogue Scale
Alias
- UMLS CUI-1
- C2959685
- UMLS CUI-2
- C0205341
Description
Date/ Time of assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Nose not runny/Nose extremely runny
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C1260880
Description
Nose clear/Nose completely blocked
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0027424
Description
Nose not itchy/Nose extremely itchy
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0850060
Description
Nose not sore/Nose as sore as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0857495
Description
Nose not dry/Nose as dry as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0231919
Description
Throat not sore/Throat as sore as it has ever been
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0242429
Description
Sense of taste normal/ Sense of taste completely abnormal
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0039336
Description
Taste nothing/Taste something very strongly
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C1301555
Description
Sense of smell normal/ Sense of smell completely abnormal
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0037361
Description
Smell nothing/Smell something very strongly
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C2712084
Description
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0231918
Description
Repeat Visual Nasal Endoscopy
Alias
- UMLS CUI-1
- C0189024
- UMLS CUI-2
- C0205341
Description
Date/ Time of Assessment
Data type
datetime
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C1264639
Description
Left Nostril Colour
Data type
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720438
Description
Right Nostril Colour
Data type
text
Alias
- UMLS CUI [1,1]
- C0475705
- UMLS CUI [1,2]
- C1720679
Description
Left nostril concha media turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720438
Description
Left nostril concha inferior turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720438
- UMLS CUI [1,4]
- C0038999
Description
Right nostril concha media turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0205098
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Description
Right nostril concha inferior turbinate swelling
Data type
text
Alias
- UMLS CUI [1,1]
- C1266928
- UMLS CUI [1,2]
- C0542339
- UMLS CUI [1,3]
- C1720679
- UMLS CUI [1,4]
- C0038999
Description
Alignment of the Septum
Data type
text
Alias
- UMLS CUI [1]
- C0027432
Description
Severity of right deviation
Data type
text
Alias
- UMLS CUI [1,1]
- C0232296
- UMLS CUI [1,2]
- C0439793
Description
Severity of left deviation
Data type
text
Alias
- UMLS CUI [1,1]
- C0232297
- UMLS CUI [1,2]
- C0439793
Description
Left nostril secretions
Data type
text
Alias
- UMLS CUI [1,1]
- C1720438
- UMLS CUI [1,2]
- C0036537
Description
Right nostril secretions
Data type
text
Alias
- UMLS CUI [1,1]
- C1720679
- UMLS CUI [1,2]
- C0036537
Description
Nasal infection
Data type
text
Alias
- UMLS CUI [1]
- C0555970
Description
Post Nasal Drip
Data type
text
Alias
- UMLS CUI [1]
- C1739415
Description
Crusting
Data type
text
Alias
- UMLS CUI [1]
- C0205204
Description
Signs of Bleeding
Data type
text
Alias
- UMLS CUI [1]
- C0019080
Description
If signs of bleeding, specify location
Data type
text
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C2348235
Description
Presence of nasal polyps
Data type
text
Alias
- UMLS CUI [1]
- C0027430
Description
If presece of nasal polyps, specify location
Data type
text
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C2348235
Similar models
Logs/ Repeats - 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood; Repeat Visual Analogue Scale; Repeat Nasal Endoscopy; Repeat Visual Nasal Examination
C2826293 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C2826293 (UMLS CUI [1,2])
C2216025 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0005767 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0205341 (UMLS CUI-2)
C1264639 (UMLS CUI [1,2])
C0205341 (UMLS CUI-2)
C1264639 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,2])
C0205098 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0542339 (UMLS CUI [1,2])
C1720438 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0205098 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0542339 (UMLS CUI [1,2])
C1720679 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0439793 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
C0036537 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
No comments