ID
22988
Description
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive
Keywords
Versions (2)
- 6/19/17 6/19/17 -
- 9/20/21 9/20/21 -
Uploaded on
June 19, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Main CRF (Treatment Period 3, Day 3-6) - GSK Milveterol COPD 100527
Main CRF (Treatment Period 3, Day 3-6) - GSK Milveterol COPD 100527
Description
12-Lead Electrocardiogram (Treatment period 3, Day 3-6)
Alias
- UMLS CUI-1
- C0430456
Description
Sequence number
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0430456
Description
Date of ECG
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826640
Description
Study day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Time relative to dosing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Description
Time of ECG
Data type
time
Measurement units
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Description
Ventricular rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C2189285
Description
PR Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
QT Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0577807
Description
QTc Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0855331
Description
ECG finding
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
ECG abnormality clinically significant
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2985739
Description
FEV1 (Treatment Period 3, Day 3-6)
Alias
- UMLS CUI-1
- C0429706
Description
Sequence number
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0429706
Description
Date of FEV1
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
Description
Study day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Time relative to dosing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Description
Time of FEV1 measurement
Data type
time
Measurement units
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Description
Reading 1
Data type
float
Measurement units
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Description
Reading 2
Data type
float
Measurement units
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Description
Pharmacokinetic sampling (Treatment Period 3, Day 5-6)
Alias
- UMLS CUI-1
- C0201734
Description
Sequence number pharmacokinetic study
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0201734
Description
Date of pharmacokinetic study
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0201734
Description
Study day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Time relative to dosing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Description
Time of pharmacokinetic study
Data type
time
Measurement units
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0201734
Description
Sample number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0201734
Description
Blood sample taken
Data type
boolean
Alias
- UMLS CUI [1]
- C1277698
Description
Potassium (Treatment Period 3, Day 5-6)
Alias
- UMLS CUI-1
- C0202194
Description
Sequence number
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0202194
Description
Date of measurement
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0202194
Description
Study day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Time relative to dosing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Description
Time of measurement
Data type
time
Measurement units
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0202194
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0337438
Description
Test result
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0202194
Description
Investigational Product (Treatment period 3, Day 3-6)
Alias
- UMLS CUI-1
- C0304229
Description
Date of dose
Data type
date
Measurement units
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
Study day
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
Start time of inhalation
Data type
time
Measurement units
- hh:mm
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Description
End time of inhalation
Data type
time
Measurement units
- hh:mm
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Description
investigational product change of administration
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0443172
Description
Specification investigational product change of administration
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C3469597
- UMLS CUI [1,4]
- C0443172
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Main CRF (Treatment Period 3, Day 3-6) - GSK Milveterol COPD 100527
C0518766 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0013798 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0201734 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
C0202194 (UMLS CUI [1,2])
C0202194 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0202194 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
C0202194 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0001559 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])