ID

38147

Beschrijving

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

Trefwoorden

Versies (2)
  1. 22-09-19 22-09-19 -
  2. 24-10-19 24-10-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 september 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
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.

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

Engels

Unscheduled Visit

1 Formulieren  
  1. StudyEvent: ODM
    1. Unscheduled Visit
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Beschrijving

Study Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschrijving

Patient name

Datatype

text

Alias
UMLS CUI [1]
C1299487
Patient No
Beschrijving

Patients, Identification number

Datatype

integer

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

Date of Visit/Assessment

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

Date of visit; Assessment Date

Datatype

date

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

Status of ECG

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

Electrocardiogram, Status

Datatype

boolean

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

Status of Vital Signs

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

Vital signs, Status

Datatype

boolean

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

Status of Lab

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

Laboratory Procedures, Status

Datatype

boolean

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

Medications Recorded In-Clinic

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

Concomitant Agent

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Sequence Number
Beschrijving

Concomitant Agent, Sequence Number

Datatype

integer

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

Concomitant Agent, Medication name

Datatype

text

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

Concomitant Agent, Medication name, Reported Term

Datatype

text

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

Concomitant Agent, Pharmaceutical Preparations, Synonym

Datatype

text

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

Concomitant Agent, Code

Datatype

text

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

Concomitant Agent, Code, Failed

Datatype

text

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

Concomitant Agent, Date in time

Datatype

date

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

Concomitant Agent, Time

Datatype

time

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Beschrijving

Body Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Body Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschrijving

Body mass index

Datatype

float

Maateenheden
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Blood pressure(1st Reading) - Systolic
Beschrijving

Systolic Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(1st Reading) - Diastolic
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Blood pressure(2nd Reading) - Systolic
Beschrijving

Systolic Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(2nd Reading) - Diastolic
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Blood pressure(3rd Reading) - Systolic
Beschrijving

Systolic Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(3rd Reading) - Diastolic
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Average of the lowest two blood pressure readings - Systolic
Beschrijving

Systolic Pressure, Low, Average

Datatype

integer

Maateenheden
  • 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
Beschrijving

Diastolic blood pressure, Low, Average

Datatype

integer

Maateenheden
  • 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
Beschrijving

Systolic Pressure, Low, Average, Screening procedure

Datatype

integer

Maateenheden
  • 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
Beschrijving

Diastolic blood pressure, Low, Average, Screening procedure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992C0220908
mmHg
12-Lead ECG
Beschrijving

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Beschrijving

12 lead ECG, Date in time

Datatype

date

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

12 lead ECG, Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Beschrijving

12 lead ECG, P-R Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beschrijving

12 lead ECG, QRS complex duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beschrijving

12 lead ECG, QT Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beschrijving

12 lead ECG, Electrocardiogram QT corrected interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Is this a repeat ECG?
Beschrijving

12 lead ECG, Repeat

Datatype

boolean

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

12 lead ECG, Repeat, Reason and justification

Datatype

text

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

12 lead ECG, Result

Datatype

text

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

12 lead ECG, Result, Change status

Datatype

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?
Beschrijving

12 lead ECG, Result, Change status, Clinical Significance

Datatype

text

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

12 lead ECG, QRS Axis

Datatype

text

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

12 lead ECG, RR interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0489636
msec
Liver Events Assessment
Beschrijving

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?
Beschrijving

Liver, Adverse Event, Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0220825
Terug naar het begin van de pagina

Similar models

Unscheduled Visit

1 Formulieren
  1. StudyEvent: ODM
    1. Unscheduled Visit
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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