ID

38147

Descripción

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Palabras clave

Versiones (2)
  1. 22/9/19 22/9/19 -
  2. 24/10/19 24/10/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de septiembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

Inglés

Unscheduled Visit

1 formularios  
  1. StudyEvent: ODM
    1. Unscheduled Visit
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Descripción

Study Site

Tipo de datos

text

Alias
UMLS CUI [1]
C2825164
Patient
Descripción

Patient name

Tipo de datos

text

Alias
UMLS CUI [1]
C1299487
Patient No
Descripción

Patients, Identification number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Date of Visit/Assessment
Descripción

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Descripción

Date of visit; Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Status of ECG
Descripción

Status of ECG

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0449438
Was an ECG performed?
Descripción

Electrocardiogram, Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0449438
Status of Vital Signs
Descripción

Status of Vital Signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0449438
Were vital signs performed at this visit?
Descripción

Vital signs, Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0449438
Status of Lab
Descripción

Status of Lab

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0449438
Were labs drawn?
Descripción

Laboratory Procedures, Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0449438
Medications Recorded In-Clinic
Descripción

Medications Recorded In-Clinic

Alias
UMLS CUI-1
C2347852
Were any medications recorded on the In-Clinic Medications Taken Diary?
Descripción

Concomitant Agent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
Sequence Number
Descripción

Concomitant Agent, Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Drug Name (Trade Name preferred)
Descripción

Concomitant Agent, Medication name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Modified reported term
Descripción

Concomitant Agent, Medication name, Reported Term

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
UMLS CUI [1,3]
C2826302
GSK Drug synonym
Descripción

Concomitant Agent, Pharmaceutical Preparations, Synonym

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0871468
GSK Drug Collection code
Descripción

Concomitant Agent, Code

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
Failed coding
Descripción

Concomitant Agent, Code, Failed

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Date Taken
Descripción

Concomitant Agent, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0011008
Time Taken
Descripción

Concomitant Agent, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0040223
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Descripción

Body Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

Body Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Descripción

Body mass index

Tipo de datos

float

Unidades de medida
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Blood pressure(1st Reading) - Systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(1st Reading) - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Blood pressure(2nd Reading) - Systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(2nd Reading) - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Blood pressure(3rd Reading) - Systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(3rd Reading) - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Average of the lowest two blood pressure readings - Systolic
Descripción

Systolic Pressure, Low, Average

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992
mmHg
Average of the lowest two blood pressure readings - Diastolic
Descripción

Diastolic blood pressure, Low, Average

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992
mmHg
Average of the lowest two blood pressure readings at Screening visit - Systolic
Descripción

Systolic Pressure, Low, Average, Screening procedure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992
UMLS CUI [1,4]
C0220908
mmHg
Average of the lowest two blood pressure readings at Screening visit - Diastolic
Descripción

Diastolic blood pressure, Low, Average, Screening procedure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992C0220908
mmHg
12-Lead ECG
Descripción

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Descripción

12 lead ECG, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Heart rate
Descripción

12 lead ECG, Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Descripción

12 lead ECG, P-R Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Descripción

12 lead ECG, QRS complex duration

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Descripción

12 lead ECG, QT Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Descripción

12 lead ECG, Electrocardiogram QT corrected interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Is this a repeat ECG?
Descripción

12 lead ECG, Repeat

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205341
Yes, specify reason repeated
Descripción

12 lead ECG, Repeat, Reason and justification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0566251
Result of the ECG
Descripción

12 lead ECG, Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Change in ECG Result
Descripción

12 lead ECG, Result, Change status

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0443172
Was there a clinically significant change from baseline?
Descripción

12 lead ECG, Result, Change status, Clinical Significance

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0443172
UMLS CUI [1,4]
C2826293
QRS Axis
Descripción

12 lead ECG, QRS Axis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429012
RR interval
Descripción

12 lead ECG, RR interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0489636
msec
Liver Events Assessment
Descripción

Liver Events Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Descripción

Liver, Adverse Event, Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0220825
Volver a la parte superior de la página

Similar models

Unscheduled Visit

1 formularios
  1. StudyEvent: ODM
    1. Unscheduled Visit
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Status of ECG
C1623258 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Electrocardiogram, Status
Item
Was an ECG performed?
boolean
C1623258 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Item Group
Status of Vital Signs
C0518766 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Vital signs, Status
Item
Were vital signs performed at this visit?
boolean
C0518766 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Item Group
Status of Lab
C0022885 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Laboratory Procedures, Status
Item
Were labs drawn?
boolean
C0022885 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Item Group
Medications Recorded In-Clinic
C2347852 (UMLS CUI-1)
Concomitant Agent
Item
Were any medications recorded on the In-Clinic Medications Taken Diary?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Agent, Medication name
Item
Drug Name (Trade Name preferred)
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Agent, Medication name, Reported Term
Item
Modified reported term
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
Concomitant Agent, Pharmaceutical Preparations, Synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
Concomitant Agent, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Concomitant Agent, Code, Failed
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Concomitant Agent, Date in time
Item
Date Taken
date
C2347852 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Concomitant Agent, Time
Item
Time Taken
time
C2347852 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(1st Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(1st Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(2nd Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(2nd Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(3rd Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(3rd Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Systolic Pressure, Low, Average
Item
Average of the lowest two blood pressure readings - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Diastolic blood pressure, Low, Average
Item
Average of the lowest two blood pressure readings - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Systolic Pressure, Low, Average, Screening procedure
Item
Average of the lowest two blood pressure readings at Screening visit - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Diastolic blood pressure, Low, Average, Screening procedure
Item
Average of the lowest two blood pressure readings at Screening visit - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992C0220908 (UMLS CUI [1,3])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, P-R Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
12 lead ECG, Repeat
Item
Is this a repeat ECG?
boolean
C0430456 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item
Yes, specify reason repeated
text
C0430456 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
12 lead ECG, Repeat, Reason and justification
Code List
Yes, specify reason repeated
CL Item
Safety (1)
CL Item
Other (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, clinically significant  (3)
CL Item
No result (not available) (4)
Item
Change in ECG Result
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
12 lead ECG, Result
Code List
Change in ECG Result
CL Item
Clinically significant change from [protocol specific timepoint] favourable (1)
CL Item
Clinically significant change from [protocol specified timepoint] unfavourable  (2)
CL Item
No change or insignificant change from [protocol specified timepoint] (3)
CL Item
No result (not available) (4)
Item
Was there a clinically significant change from baseline?
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
12 lead ECG, Result
Code List
Was there a clinically significant change from baseline?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (3)
12 lead ECG, QRS Axis
Item
QRS Axis
text
C0430456 (UMLS CUI [1,1])
C0429012 (UMLS CUI [1,2])
12 lead ECG, RR interval
Item
RR interval
integer
C0430456 (UMLS CUI [1,1])
C0489636 (UMLS CUI [1,2])
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Liver, Adverse Event, Evaluation
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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