ID

38976

Description

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

Keywords

Versions (1)
  1. 11/17/19 11/17/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 17, 2019

DOI

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License

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

English

Investigational Product (Dose)

1 forms  
Day 21 AM Dose
Description

Day 21 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Investigational product container number
Description

Experimental drug, Container, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0237753
Day 21 PM Dose
Description

Day 21 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 22 AM Dose
Description

Day 22 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 22 PM Dose
Description

Day 22 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 23 AM Dose
Description

Day 23 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 23 PM Dose
Description

Day 23 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 24 AM Dose
Description

Day 24 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 24 PM Dose
Description

Day 24 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 25 AM Dose
Description

Day 25 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 25 PM Dose
Description

Day 25 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 26 AM Dose
Description

Day 26 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 26 PM Dose
Description

Day 26 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 27 AM Dose
Description

Day 27 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 27 PM Dose
Description

Day 27 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Treatment Confirmation
Description

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Therapeutic procedure, Correct

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
No, record reason(s)
Description

Therapeutic procedure, Wrong, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
Day 28 AM Dose
Description

Day 28 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Investigational product container number
Description

Experimental drug, Container, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0237753
Investigational product container number
Description

Experimental drug, Container, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0237753
Day 28 PM Dose
Description

Day 28 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 29 AM Dose
Description

Day 29 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 29 PM Dose
Description

Day 29 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 30 AM Dose
Description

Day 30 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 30 PM Dose
Description

Day 30 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 31 AM Dose
Description

Day 31 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 31 PM Dose
Description

Day 31 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 32 AM Dose
Description

Day 32 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 32 PM Dose
Description

Day 32 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 33 AM Dose
Description

Day 33 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 33 PM Dose
Description

Day 33 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 34 AM Dose
Description

Day 34 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 34 PM Dose
Description

Day 34 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 35 AM Dose
Description

Day 35 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 35 PM Dose
Description

Day 35 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 36 AM Dose
Description

Day 36 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 36 PM Dose
Description

Day 36 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 37 AM Dose
Description

Day 37 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 37 PM Dose
Description

Day 37 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 38 AM Dose
Description

Day 38 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 38 PM Dose
Description

Day 38 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 39 AM Dose
Description

Day 39 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 39 PM Dose
Description

Day 39 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 40 AM Dose
Description

Day 40 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 40 PM Dose
Description

Day 40 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 41 AM Dose
Description

Day 41 AM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0332170
Date/time of dose
Description

Experimental drug, Dosage, Morning, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Day 41 PM Dose
Description

Day 41 PM Dose

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0587117
Date/time of dose
Description

Experimental drug, Dosage, Evening, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Treatment Confirmation
Description

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Therapeutic procedure, Correct

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
No, record reason(s)
Description

Therapeutic procedure, Wrong, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
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Similar models

Investigational Product (Dose)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Day 21 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Experimental drug, Container, Numbers
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item Group
Day 21 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 22 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 22 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 23 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 23 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 24 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 24 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 25 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 25 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 26 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 26 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 27 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 27 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic procedure, Correct
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Therapeutic procedure, Wrong, Reason and justification
Item
No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Day 28 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Experimental drug, Container, Numbers
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Experimental drug, Container, Numbers
Item
Investigational product container number
integer
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item Group
Day 28 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 29 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 29 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 30 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 30 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 31 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 31 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 32 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 32 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 33 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 33 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 34 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 34 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 35 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 35 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 36 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 36 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 37 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 37 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 38 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 38 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 39 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 39 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 40 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 40 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 41 AM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Experimental drug, Dosage, Morning, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Day 41 PM Dose
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Experimental drug, Dosage, Evening, Date in time, Time
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic procedure, Correct
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Therapeutic procedure, Wrong, Reason and justification
Item
No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
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