ID

40351

Beschrijving

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

Trefwoorden

Versies (1)
  1. 11-04-20 11-04-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 april 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883

Engels

Pharmacogenetics; Inclusion; Temperature; Status of Treatment Blind; Study Conclusion

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Study
Beschrijving

Study

Datatype

text

Alias
UMLS CUI [1]
C2603343
Subject
Beschrijving

Subject

Datatype

text

Alias
UMLS CUI [1]
C0681850
Collected by
Beschrijving

Collected by

Datatype

text

Alias
UMLS CUI [1]
C3244127
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study Phase
Beschrijving

Study Phase

Datatype

text

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C2603343
Session
Beschrijving

Session

Datatype

text

Alias
UMLS CUI [1]
C1883017
PGx Consent
Beschrijving

PGx Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
PGx Consent - Physical Date
Beschrijving

PGx Consent - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
PGx Consent - Time
Beschrijving

PGx Consent - Time

Datatype

time

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0040223
PGx Consent - Day
Beschrijving

PGx Consent - Day

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0439228
PGx Consent - Hour
Beschrijving

PGx Consent - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0439227
h
PGx Consent - Min
Beschrijving

PGx Consent - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0439232
min
PGx Consent - Informed Consent obtained?
Beschrijving

PGx Consent - Informed Consent obtained?

Datatype

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
PGx Consent - Date obtained
Beschrijving

PGx Consent - Date obtained

Datatype

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
PGx Consent - Blood sample collection date
Beschrijving

PGx Consent - Blood sample collection date

Datatype

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0005834
PGx Consent - Withdrawal of PGx consent?
Beschrijving

PGx Consent - Withdrawal of PGx consent?

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C2349954
PGx Consent - Request for sample destruction?
Beschrijving

PGx Consent - Request for sample destruction?

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [2,1]
C1272683
UMLS CUI [2,2]
C1948029
UMLS CUI [2,3]
C0178913
PGx Consent - Reason for sample destruction
Beschrijving

PGx Consent - Reason for sample destruction

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [2,1]
C1948029
UMLS CUI [2,2]
C0178913
UMLS CUI [2,3]
C0392360
Inclusion
Beschrijving

Inclusion

Alias
UMLS CUI-1
C1512693
Inclusion - Physical Date
Beschrijving

Inclusion - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0011008
Inclusion - Time
Beschrijving

Inclusion - Time

Datatype

time

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0040223
Inclusion - Day
Beschrijving

Inclusion - Day

Datatype

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0439228
Inclusion- Hour
Beschrijving

Inclusion- Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0439227
h
Inclusion - Min
Beschrijving

Inclusion - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0439232
min
Did the subject meet all the entry criteria
Beschrijving

Did the subject meet all the entry criteria

Datatype

boolean

Alias
UMLS CUI [1]
C1516637
Temperature
Beschrijving

Temperature

Alias
UMLS CUI-1
C0005903
Temperature - Physical Date
Beschrijving

Temperature - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0011008
Temperature - Time
Beschrijving

Temperature - Time

Datatype

time

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0040223
Temperature - Day
Beschrijving

Temperature - Day

Datatype

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
Temperature - Hour
Beschrijving

Temperature - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439227
h
Temperature - Min
Beschrijving

Temperature - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439232
min
Tympanic Temperature
Beschrijving

Tympanic Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0041445
UMLS CUI [1,2]
C0005903
°C
Status of Treatment Blind
Beschrijving

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Status of Treatment Blind - Physical Date
Beschrijving

Status of Treatment Blind - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0011008
Status of Treatment Blind - Time
Beschrijving

Status of Treatment Blind - Time

Datatype

time

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0040223
Status of Treatment Blind - Day
Beschrijving

Status of Treatment Blind - Day

Datatype

text

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0439228
Status of Treatment Blind - Hour
Beschrijving

Status of Treatment Blind - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0439227
h
Status of Treatment Blind - Min
Beschrijving

Status of Treatment Blind - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0439232
min
Was the Treatment blind broken during the study?
Beschrijving

If Yes complete AE,SAE and/or Investigational product forms as appropriate

Datatype

boolean

Alias
UMLS CUI [1]
C3897431
Date and Time blind broken
Beschrijving

Date and Time blind broken

Datatype

datetime

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C1264639
Reason blind broken
Beschrijving

Reason blind broken

Datatype

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Study Conclusion
Beschrijving

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Study Conclusion - Physical Date
Beschrijving

Study Conclusion - Physical Date

Datatype

date

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0011008
Study Conclusion - Time
Beschrijving

Study Conclusion - Time

Datatype

time

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0040223
Study Conclusion - Day
Beschrijving

Study Conclusion - Day

Datatype

text

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0439228
Study Conclusion - Hour
Beschrijving

Study Conclusion - Hour

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0439227
h
Study Conclusion - Min
Beschrijving

Study Conclusion - Min

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0439232
min
Date of last contact (FU date if completed as planned)
Beschrijving

Date of last contact (FU date if completed as planned)

Datatype

date

Alias
UMLS CUI [1]
C0805839
UMLS CUI [2]
C3694716
Was the subject withdrawn from the study?
Beschrijving

Was the subject withdrawn from the study?

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
Date of decision to withdraw
Beschrijving

Date of decision to withdraw

Datatype

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Terug naar het begin van de pagina

Similar models

Pharmacogenetics; Inclusion; Temperature; Status of Treatment Blind; Study Conclusion

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study
Item
Study
text
C2603343 (UMLS CUI [1])
Subject
Item
Subject
text
C0681850 (UMLS CUI [1])
Collected by
Item
Collected by
text
C3244127 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Study Phase
Item
Study Phase
text
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Session
Item
Session
text
C1883017 (UMLS CUI [1])
Item Group
PGx Consent
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
PGx Consent - Physical Date
Item
PGx Consent - Physical Date
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
PGx Consent - Time
Item
PGx Consent - Time
time
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
PGx Consent - Day
Item
PGx Consent - Day
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
PGx Consent - Hour
Item
PGx Consent - Hour
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
PGx Consent - Min
Item
PGx Consent - Min
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item
PGx Consent - Informed Consent obtained?
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
PGx Consent - Informed Consent obtained?
Code List
PGx Consent - Informed Consent obtained?
CL Item
No- Subject Declined  (01)
CL Item
Yes  (04)
CL Item
No- Other  (03)
CL Item
No- Subject not asked by investigator (02)
PGx Consent - Date obtained
Item
PGx Consent - Date obtained
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
PGx Consent - Blood sample collection date
Item
PGx Consent - Blood sample collection date
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Item
PGx Consent - Withdrawal of PGx consent?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
PGx Consent - Withdrawal of PGx consent?
Code List
PGx Consent - Withdrawal of PGx consent?
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
Item
PGx Consent - Request for sample destruction?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C1272683 (UMLS CUI [2,1])
C1948029 (UMLS CUI [2,2])
C0178913 (UMLS CUI [2,3])
PGx Consent - Request for sample destruction?
Code List
PGx Consent - Request for sample destruction?
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
Item
PGx Consent - Reason for sample destruction
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C1948029 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
PGx Consent - Reason for sample destruction
Code List
PGx Consent - Reason for sample destruction
CL Item
Subject's Request  (01)
CL Item
Not Applicable  (04)
CL Item
Other  (03)
CL Item
Screen Failure (02)
Item Group
Inclusion
C1512693 (UMLS CUI-1)
Inclusion - Physical Date
Item
Inclusion - Physical Date
date
C1512693 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Inclusion - Time
Item
Inclusion - Time
time
C1512693 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Inclusion - Day
Item
Inclusion - Day
text
C1512693 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Inclusion- Hour
Item
Inclusion- Hour
integer
C1512693 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Inclusion - Min
Item
Inclusion - Min
integer
C1512693 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Did the subject meet all the entry criteria
Item
Did the subject meet all the entry criteria
boolean
C1516637 (UMLS CUI [1])
Item Group
Temperature
C0005903 (UMLS CUI-1)
Temperature - Physical Date
Item
Temperature - Physical Date
date
C0005903 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature - Time
Item
Temperature - Time
time
C0005903 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Temperature - Day
Item
Temperature - Day
text
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Temperature - Hour
Item
Temperature - Hour
integer
C0005903 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Temperature - Min
Item
Temperature - Min
integer
C0005903 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Tympanic Temperature
Item
Tympanic Temperature
float
C0041445 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Status of Treatment Blind - Physical Date
Item
Status of Treatment Blind - Physical Date
date
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Status of Treatment Blind - Time
Item
Status of Treatment Blind - Time
time
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Status of Treatment Blind - Day
Item
Status of Treatment Blind - Day
text
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Status of Treatment Blind - Hour
Item
Status of Treatment Blind - Hour
integer
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Status of Treatment Blind - Min
Item
Status of Treatment Blind - Min
integer
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Was the Treatment blind broken during the study?
Item
Was the Treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date and Time blind broken
Item
Date and Time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify score 1 (2)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study Conclusion - Physical Date
Item
Study Conclusion - Physical Date
date
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Study Conclusion - Time
Item
Study Conclusion - Time
time
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Study Conclusion - Day
Item
Study Conclusion - Day
text
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Study Conclusion - Hour
Item
Study Conclusion - Hour
integer
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Study Conclusion - Min
Item
Study Conclusion - Min
integer
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Date of last contact (FU date if completed as planned)
Item
Date of last contact (FU date if completed as planned)
date
C0805839 (UMLS CUI [1])
C3694716 (UMLS CUI [2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Date of decision to withdraw
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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