ID

38974

Beschreibung

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

Stichworte

Versionen (1)
  1. 17.11.19 17.11.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. November 2019

DOI

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Lizenz

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

Englisch

Investigational Product (Dose)

1 Formulare  
Day 8 AM Dose
Beschreibung

Day 8 AM Dose

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

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

Datentyp

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
Beschreibung

Experimental drug, Container, Numbers

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0237753
Day 8 PM Dose
Beschreibung

Day 8 PM Dose

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

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

Datentyp

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 9 AM Dose
Beschreibung

Day 9 AM Dose

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

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

Datentyp

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 9 PM Dose
Beschreibung

Day 9 PM Dose

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

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

Datentyp

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
Beschreibung

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?
Beschreibung

Therapeutic procedure, Correct

Datentyp

boolean

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

Therapeutic procedure, Wrong, Reason and justification

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
Day 10 AM Dose
Beschreibung

Day 10 AM Dose

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

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

Datentyp

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 10 PM Dose
Beschreibung

Day 10 PM Dose

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

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

Datentyp

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 11 AM Dose
Beschreibung

Day 11 AM Dose

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

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

Datentyp

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 11 PM Dose
Beschreibung

Day 11 PM Dose

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

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

Datentyp

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 12 AM Dose
Beschreibung

Day 12 AM Dose

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

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

Datentyp

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 12 PM Dose
Beschreibung

Day 12 PM Dose

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

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

Datentyp

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 13 AM Dose
Beschreibung

Day 13 AM Dose

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

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

Datentyp

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 13 PM Dose
Beschreibung

Day 13 PM Dose

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

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

Datentyp

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
Beschreibung

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?
Beschreibung

Therapeutic procedure, Correct

Datentyp

boolean

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

Therapeutic procedure, Wrong, Reason and justification

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
Day 14 AM Dose
Beschreibung

Day 14 AM Dose

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

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

Datentyp

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
Beschreibung

Experimental drug, Container, Numbers

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0237753
Day 14 PM Dose
Beschreibung

Day 14 PM Dose

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

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

Datentyp

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 15 AM Dose
Beschreibung

Day 15 AM Dose

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

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

Datentyp

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 15 PM Dose
Beschreibung

Day 15 PM Dose

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

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

Datentyp

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 16 AM Dose
Beschreibung

Day 16 AM Dose

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

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

Datentyp

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 16 PM Dose
Beschreibung

Day 16 PM Dose

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

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

Datentyp

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 17 AM Dose
Beschreibung

Day 17 AM Dose

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

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

Datentyp

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 17 PM Dose
Beschreibung

Day 17 PM Dose

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

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

Datentyp

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 18 AM Dose
Beschreibung

Day 18 AM Dose

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

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

Datentyp

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 18 PM Dose
Beschreibung

Day 18 PM Dose

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

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

Datentyp

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 19 AM Dose
Beschreibung

Day 19 AM Dose

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

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

Datentyp

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 19 PM Dose
Beschreibung

Day 19 PM Dose

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

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

Datentyp

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 20 AM Dose
Beschreibung

Day 20 AM Dose

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

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

Datentyp

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 20 PM Dose
Beschreibung

Day 20 PM Dose

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

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

Datentyp

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
Beschreibung

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?
Beschreibung

Therapeutic procedure, Correct

Datentyp

boolean

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

Therapeutic procedure, Wrong, Reason and justification

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
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Ähnliche Modelle

Investigational Product (Dose)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Day 8 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 8 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 9 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 9 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 10 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 10 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 11 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 11 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 12 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 12 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 13 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 13 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 14 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 14 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 15 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 15 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 16 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 16 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 17 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 17 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 18 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 18 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 19 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 19 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 20 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 20 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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