ID

38147

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2019-09-22 2019-09-22 -
  2. 2019-10-24 2019-10-24 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

22 september 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

Engelsk

Unscheduled Visit

1 Formulär  
  1. StudyEvent: ODM
    1. Unscheduled Visit
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Beskrivning

Study Site

Datatyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beskrivning

Patient name

Datatyp

text

Alias
UMLS CUI [1]
C1299487
Patient No
Beskrivning

Patients, Identification number

Datatyp

integer

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

Date of Visit/Assessment

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

Date of visit; Assessment Date

Datatyp

date

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

Status of ECG

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

Electrocardiogram, Status

Datatyp

boolean

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

Status of Vital Signs

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

Vital signs, Status

Datatyp

boolean

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

Status of Lab

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

Laboratory Procedures, Status

Datatyp

boolean

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

Medications Recorded In-Clinic

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

Concomitant Agent

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Sequence Number
Beskrivning

Concomitant Agent, Sequence Number

Datatyp

integer

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

Concomitant Agent, Medication name

Datatyp

text

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

Concomitant Agent, Medication name, Reported Term

Datatyp

text

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

Concomitant Agent, Pharmaceutical Preparations, Synonym

Datatyp

text

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

Concomitant Agent, Code

Datatyp

text

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

Concomitant Agent, Code, Failed

Datatyp

text

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

Concomitant Agent, Date in time

Datatyp

date

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

Concomitant Agent, Time

Datatyp

time

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Beskrivning

Body Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beskrivning

Body Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beskrivning

Body mass index

Datatyp

float

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

Systolic Pressure

Datatyp

integer

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

Diastolic blood pressure

Datatyp

integer

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

Systolic Pressure

Datatyp

integer

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

Diastolic blood pressure

Datatyp

integer

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

Systolic Pressure

Datatyp

integer

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

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

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

Systolic Pressure, Low, Average

Datatyp

integer

Måttenheter
  • 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
Beskrivning

Diastolic blood pressure, Low, Average

Datatyp

integer

Måttenheter
  • 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
Beskrivning

Systolic Pressure, Low, Average, Screening procedure

Datatyp

integer

Måttenheter
  • 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
Beskrivning

Diastolic blood pressure, Low, Average, Screening procedure

Datatyp

integer

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

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Beskrivning

12 lead ECG, Date in time

Datatyp

date

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

12 lead ECG, Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Beskrivning

12 lead ECG, P-R Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beskrivning

12 lead ECG, QRS complex duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beskrivning

12 lead ECG, QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beskrivning

12 lead ECG, Electrocardiogram QT corrected interval

Datatyp

integer

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

12 lead ECG, Repeat

Datatyp

boolean

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

12 lead ECG, Repeat, Reason and justification

Datatyp

text

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

12 lead ECG, Result

Datatyp

text

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

12 lead ECG, Result, Change status

Datatyp

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?
Beskrivning

12 lead ECG, Result, Change status, Clinical Significance

Datatyp

text

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

12 lead ECG, QRS Axis

Datatyp

text

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

12 lead ECG, RR interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0489636
msec
Liver Events Assessment
Beskrivning

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?
Beskrivning

Liver, Adverse Event, Evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0220825
Tillbaka till toppen

Similar models

Unscheduled Visit

1 Formulär
  1. StudyEvent: ODM
    1. Unscheduled Visit
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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