ID
40313
Description
Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity
Keywords
Versions (2)
- 4/6/20 4/6/20 -
- 4/6/20 4/6/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 6, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883
Adverse Events; Demography; Height Weight; ECG
- StudyEvent: ODM
Description
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
User ID of reviewing physician populated by system.
Data type
text
Alias
- UMLS CUI [1,1]
- C0035173
- UMLS CUI [1,2]
- C3166277
Description
Verbatim AE
Data type
text
Alias
- UMLS CUI [1]
- C2699044
Description
Term sent for MedDRA coding
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1140263
Description
AE - MedDRA Code
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3898442
Description
Serious AE
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
SAE
Data type
integer
Alias
- UMLS CUI [1]
- C1519255
Description
AE - Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2697888
Description
AE - Start time
Data type
time
Alias
- UMLS CUI [1]
- C2697889
Description
AE - Continuing
Data type
boolean
Alias
- UMLS CUI [1]
- C2826663
Description
AE - Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0877248
Description
AE - Stop time
Data type
time
Alias
- UMLS CUI [1]
- C2826658
Description
AE - Number of episodes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Description
AE - Intensity
Data type
text
Alias
- UMLS CUI [1]
- C1710066
Description
AE - Action
Data type
text
Alias
- UMLS CUI [1]
- C2826626
Description
AE - Therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
AE - Outcome
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
AE - Experience Course
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
AE - Intensity (maximum)
Data type
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0806909
Description
AE - Action with respect to Investigational Drug
Data type
text
Alias
- UMLS CUI [1]
- C2826626
Description
AE - Total Number episodes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
- UMLS CUI [1,3]
- C0439810
Description
AE - Is there a reasonable possibility that the AE may have been caused by the Investigational Product?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
AE - Corrective Therapy
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
Was patient withdrawn due to this AE?
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0877248
Description
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Description
SAE - Collected
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1516698
Description
Enter all that apply
Data type
integer
Alias
- UMLS CUI [1]
- C3828190
Description
2. Did the SAE abate
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Description
3. If study medication was interrupted, stopped, or dose reduced: Was study medication reintroduced
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0420247
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0376495
Description
3. If study medication was reintroduced, did SAE recur?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0376495
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Description
4. If Relationship to Investigational drug was NOT RELATED or UNLIKELY choose an assessment. The SAE is probably associated with
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
5. Please provide details supporting the selection made in item 4
Data type
text
Alias
- UMLS CUI [1]
- C1522508
Description
Please provide a brief narrative description of the SAE
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Was the randomization code broken at the investigational site
Data type
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0805701
Description
Randomization/study medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0304229
Description
Form activated if SAE_Reason = Fatal
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Form activated if SAE_Reason = Fatal
Data type
text
Alias
- UMLS CUI [1]
- C0007465
Description
Form activated if SAE_Reason = Fatal
Data type
boolean
Alias
- UMLS CUI [1]
- C0004398
Description
Dorm activated if SAE_Reason = Fatal
Data type
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0011900
Description
SAE Report signed by:
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0684224
- UMLS CUI [1,3]
- C1519316
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Demography - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C2985720
Description
Demography - Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0040223
Description
Demography - Day
Data type
text
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0439228
Description
Demography - Hour
Data type
integer
Measurement units
- h
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0439227
Description
Demography - Min
Data type
integer
Measurement units
- min
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0439232
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
integer
Alias
- UMLS CUI [1]
- C0034510
Description
Race Other
Data type
integer
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
Description
Subject Type
Data type
text
Alias
- UMLS CUI [1]
- C2348569
Description
Group of Patient when SUBTYPE = Patient (Normal entered where SUBTYPE = volunteer)
Data type
text
Alias
- UMLS CUI [1]
- C1522242
Description
Height Weight
Alias
- UMLS CUI-1
- C0005890
- UMLS CUI-2
- C0005910
Description
Height Weight - Physical Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C2826643
Description
Height Weight - Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0040223
Description
Height Weight - Day
Data type
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0439228
Description
Height Weight - Hour
Data type
integer
Measurement units
- h
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0439227
Description
Height Weight - Min
Data type
integer
Measurement units
- min
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0439232
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
ECG
Alias
- UMLS CUI-1
- C1623258
Description
ECG Date
Data type
date
Alias
- UMLS CUI [1]
- C2826640
Description
ECG Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Description
ECG Day
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0439228
Description
ECG Hour
Data type
integer
Measurement units
- h
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0439227
Description
ECG Min
Data type
integer
Measurement units
- min
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0439232
Description
ECG Normal
Data type
text
Alias
- UMLS CUI [1]
- C0522054
Description
Ventricular Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C2189285
Description
PR Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0520880
Description
QT Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
QTc Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0489625
Description
ECG Interpretation
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Description
ECG Interpretation
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Description
ECG Holter
Alias
- UMLS CUI-1
- C0013801
Description
ECG Holter Day
Data type
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0439228
Description
ECG Holter Hour
Data type
integer
Measurement units
- h
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0439227
Description
ECG Holter Min
Data type
integer
Measurement units
- min
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0439232
Description
ECG Recording Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
Description
ECG Holter Start time
Data type
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1301880
Description
ECG Recording Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
Description
ECG Holter Stop Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1522314
Description
ECG Holter - Type of Monitoring
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0332307
Description
ECG Holter Normal
Data type
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0522054
Description
ECG Holter - Analysis Details
Data type
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0936012
- UMLS CUI [1,3]
- C1522508
Similar models
Adverse Events; Demography; Height Weight; ECG
- StudyEvent: ODM
C2603343 (UMLS CUI [1,2])
C3166277 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C4086638 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C3853704 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0376495 (UMLS CUI [2])
C0376495 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0684224 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,3])
C2985720 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,2])
C2826643 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
C0013798 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C1283169 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0936012 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])