ID

38532

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 (3)
  1. 24.10.19 24.10.19 -
  2. 24.10.19 24.10.19 -
  3. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

24. Oktober 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

Subject Migraine Diary - Treatment Period T1

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Study Contact’s Name
Beschreibung

Contact person

Datentyp

text

Alias
UMLS CUI [1]
C0337611 (contact person)
SNOMED
70862002
Clinic Telephone Number
Beschreibung

Clinic, Telephone Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0442592 (Clinic)
SNOMED
257585005
LOINC
LA24318-0
UMLS CUI [1,2]
C1515258 (Telephone Number)
SNOMED
734005006
LOINC
LP6871-0
Today’s Clinic Visit Date
Beschreibung

Clinic, Date of visit

Datentyp

date

Alias
UMLS CUI [1,1]
C0442592 (Clinic)
SNOMED
257585005
LOINC
LA24318-0
UMLS CUI [1,2]
C1320303 (Date of visit)
SNOMED
406543005
Next Scheduled Clinic Visit Date
Beschreibung

Date next clinic visit

Datentyp

date

Alias
UMLS CUI [1]
C2735342 (Date next clinic visit)
LOINC
LP96939-1
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Study Drug and Migraine Diary
Beschreibung

Study Drug and Migraine Diary

Alias
UMLS CUI-1
C0304229 (Experimental drug)
UMLS CUI-2
C0149931 (Migraine Disorders)
UMLS CUI-3
C3890583 (Subject Diary)
Date your migraine headache pain started
Beschreibung

Migraine Disorder, Pain, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0149931 (Migraine Disorders)
UMLS CUI [1,2]
C0030193 (Pain)
SNOMED
22253000
LOINC
MTHU029813
UMLS CUI [1,3]
C0808070 (Start Date)
Time your migraine headache pain started
Beschreibung

Migraine Disorder, Pain, Start time

Datentyp

time

Alias
UMLS CUI [1,1]
C0149931 (Migraine Disorders)
UMLS CUI [1,2]
C0030193 (Pain)
SNOMED
22253000
LOINC
MTHU029813
UMLS CUI [1,3]
C1301880 (Start time)
SNOMED
398201009
LOINC
LP102339-1
Time your migraine headache pain started
Beschreibung

Migraine Disorder, Pain, Start time

Datentyp

text

Alias
UMLS CUI [1,1]
C0149931 (Migraine Disorders)
UMLS CUI [1,2]
C0030193 (Pain)
SNOMED
22253000
LOINC
MTHU029813
UMLS CUI [1,3]
C1301880 (Start time)
SNOMED
398201009
LOINC
LP102339-1
Date you took the study drug
Beschreibung

Experimental drug, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229 (Experimental drug)
UMLS CUI [1,2]
C0011008 (Date in time)
SNOMED
410671006
Time you took the study drug
Beschreibung

Experimental drug, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229 (Experimental drug)
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Time you took the study drug
Beschreibung

Experimental drug, Time

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229 (Experimental drug)
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Date your migraine headache pain stopped
Beschreibung

Migraine Disorder, Pain, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0149931 (Migraine Disorders)
UMLS CUI [1,2]
C0030193 (Pain)
SNOMED
22253000
LOINC
MTHU029813
UMLS CUI [1,3]
C0806020 (End date)
SNOMED
454551000124105
LOINC
MTHU008302
Time your migraine headache pain stopped
Beschreibung

Migraine Disorder, Pain, End time

Datentyp

time

Alias
UMLS CUI [1,1]
C0149931 (Migraine Disorders)
UMLS CUI [1,2]
C0030193 (Pain)
SNOMED
22253000
LOINC
MTHU029813
UMLS CUI [1,3]
C1522314 (End Time)
SNOMED
397898000
Time your migraine headache pain stopped
Beschreibung

Migraine Disorder, Pain, End time

Datentyp

text

Alias
UMLS CUI [1,1]
C0149931 (Migraine Disorders)
UMLS CUI [1,2]
C0030193 (Pain)
SNOMED
22253000
LOINC
MTHU029813
UMLS CUI [1,3]
C1522314 (End Time)
SNOMED
397898000
Medications Taken Diary
Beschreibung

Medications Taken Diary

Alias
UMLS CUI-1
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI-2
C3890583 (Subject Diary)
Drug Name
Beschreibung

Pharmaceutical Preparations, Subject Diary, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI [1,2]
C3890583 (Subject Diary)
UMLS CUI [1,3]
C2360065 (Medication name)
LOINC
MTHU027854
Date Taken
Beschreibung

Pharmaceutical Preparations, Subject Diary, Date in time, Taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI [1,2]
C3890583 (Subject Diary)
UMLS CUI [1,3]
C0011008 (Date in time)
SNOMED
410671006
UMLS CUI [1,4]
C1883727 (Taken)
Time Taken
Beschreibung

Pharmaceutical Preparations, Subject Diary, Time, Taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI [1,2]
C3890583 (Subject Diary)
UMLS CUI [1,3]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
UMLS CUI [1,4]
C1883727 (Taken)
Time Taken
Beschreibung

Pharmaceutical Preparations, Subject Diary, Time, Taken

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI [1,2]
C3890583 (Subject Diary)
UMLS CUI [1,3]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
UMLS CUI [1,4]
C1883727 (Taken)
Blood Pressure / Exercise / Migraine Headache Pain Information
Beschreibung

Blood Pressure / Exercise / Migraine Headache Pain Information

Alias
UMLS CUI-1
C0005823 (Blood Pressure)
SNOMED
75367002
UMLS CUI-2
C0015259 (Exercise)
SNOMED
183301007
LOINC
LP61581-2
UMLS CUI-3
C014993 (undefined)
UMLS CUI-4
C1533716 (Information)
Date Blood Pressure Measurements Taken
Beschreibung

Blood pressure measurement, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C3826646 (undefined)
UMLS CUI [1,2]
C0011008 (Date in time)
SNOMED
410671006
Time Blood Pressure Measurements Taken
Beschreibung

Blood pressure measurement, Time

Datentyp

text

Alias
UMLS CUI [1,1]
C3826646 (undefined)
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Did you exercise in the 30 minutes before your blood pressure measurements were taken?
Beschreibung

Blood pressure measurement, Exercise, Before

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3826646 (undefined)
UMLS CUI [1,2]
C0015259 (Exercise)
SNOMED
183301007
LOINC
LP61581-2
UMLS CUI [1,3]
C0332152 (Before)
SNOMED
236874000
Indicate the intensity of any migraine headache pain you had at the time you took your blood pressure measurements.
Beschreibung

Blood pressure measurement, Migraine Disorders, Symptom intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C3826646 (undefined)
UMLS CUI [1,2]
C0149931 (Migraine Disorders)
UMLS CUI [1,3]
C0518690 (Symptom intensity)
Alcohol Use Diary
Beschreibung

Alcohol Use Diary

Alias
UMLS CUI-1
C0001948 (Alcohol consumption)
SNOMED
897148007
LOINC
MTHU047472
UMLS CUI-2
C3890583 (Subject Diary)
Did you consume alcohol in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
Beschreibung

Alcohol consumption, Before, Blood pressure measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948 (Alcohol consumption)
SNOMED
897148007
LOINC
MTHU047472
UMLS CUI [1,2]
C0332152 (Before)
SNOMED
236874000
UMLS CUI [1,3]
C3826646 (undefined)
Number of Units
Beschreibung

Alcohol consumption, Units, Numbers

Datentyp

integer

Alias
UMLS CUI [1,1]
C0001948 (Alcohol consumption)
SNOMED
897148007
LOINC
MTHU047472
UMLS CUI [1,2]
C0439148 (Unit)
SNOMED
767525000
UMLS CUI [1,3]
C0237753 (Numbers)
SNOMED
260299005
LOINC
LP6841-3
Date Consumed
Beschreibung

Alcohol consumption, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0001948 (Alcohol consumption)
SNOMED
897148007
LOINC
MTHU047472
UMLS CUI [1,2]
C0011008 (Date in time)
SNOMED
410671006
Time Consumed
Beschreibung

Alcohol consumption, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0001948 (Alcohol consumption)
SNOMED
897148007
LOINC
MTHU047472
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Time Consumed
Beschreibung

Alcohol consumption, Time

Datentyp

text

Alias
UMLS CUI [1,1]
C0001948 (Alcohol consumption)
SNOMED
897148007
LOINC
MTHU047472
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Caffeine Use Diary
Beschreibung

Caffeine Use Diary

Alias
UMLS CUI-1
C2006086 (caffeine use)
UMLS CUI-2
C3890583 (Subject Diary)
Did you consume caffeine in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
Beschreibung

Caffeine Use, Before, Blood pressure measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C2006086 (caffeine use)
UMLS CUI [1,2]
C0332152 (Before)
SNOMED
236874000
UMLS CUI [1,3]
C3826646 (undefined)
Number of Units
Beschreibung

Caffeine Use, Units, Numbers

Datentyp

integer

Alias
UMLS CUI [1,1]
C2006086 (caffeine use)
UMLS CUI [1,2]
C0439148 (Unit)
SNOMED
767525000
UMLS CUI [1,3]
C0237753 (Numbers)
SNOMED
260299005
LOINC
LP6841-3
Date Consumed
Beschreibung

Caffeine Use, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C2006086 (caffeine use)
UMLS CUI [1,2]
C0011008 (Date in time)
SNOMED
410671006
Time Consumed
Beschreibung

Caffeine Use, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C2006086 (caffeine use)
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Time Consumed
Beschreibung

Caffeine Use, Time

Datentyp

text

Alias
UMLS CUI [1,1]
C2006086 (caffeine use)
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Smoking/Tobacco Use Diary
Beschreibung

Smoking/Tobacco Use Diary

Alias
UMLS CUI-1
C0543414 (Tobacco use)
UMLS CUI-2
C3890583 (Subject Diary)
Did you smoke and/or use tobacco in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
Beschreibung

Tobacco Use, Before, Blood pressure measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0543414 (Tobacco use)
UMLS CUI [1,2]
C0332152 (Before)
SNOMED
236874000
UMLS CUI [1,3]
C3826646 (undefined)
Number of Units
Beschreibung

Tobacco Use, Units, Numbers

Datentyp

integer

Alias
UMLS CUI [1,1]
C0543414 (Tobacco use)
UMLS CUI [1,2]
C0439148 (Unit)
SNOMED
767525000
UMLS CUI [1,3]
C0237753 (Numbers)
SNOMED
260299005
LOINC
LP6841-3
Date Consumed
Beschreibung

Tobacco Use, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0543414 (Tobacco use)
UMLS CUI [1,2]
C0011008 (Date in time)
SNOMED
410671006
Time Consumed
Beschreibung

Tobacco Use, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0543414 (Tobacco use)
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Time Consumed
Beschreibung

Tobacco Use, Time

Datentyp

text

Alias
UMLS CUI [1,1]
C0543414 (Tobacco use)
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
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Ähnliche Modelle

Subject Migraine Diary - Treatment Period T1

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Contact person
Item
Study Contact’s Name
text
C0337611 (UMLS CUI [1])
Clinic, Telephone Number
Item
Clinic Telephone Number
integer
C0442592 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Clinic, Date of visit
Item
Today’s Clinic Visit Date
date
C0442592 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])
Date next clinic visit
Item
Next Scheduled Clinic Visit Date
date
C2735342 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Study Drug and Migraine Diary
C0304229 (UMLS CUI-1)
C0149931 (UMLS CUI-2)
C3890583 (UMLS CUI-3)
Migraine Disorder, Pain, Start Date
Item
Date your migraine headache pain started
date
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Migraine Disorder, Pain, Start time
Item
Time your migraine headache pain started
time
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Time your migraine headache pain started
text
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Migraine Disorder, Pain, Start time
Code List
Time your migraine headache pain started
CL Item
AM (1)
CL Item
PM (2)
Experimental drug, Date in time
Item
Date you took the study drug
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Experimental drug, Time
Item
Time you took the study drug
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time you took the study drug
text
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Experimental drug, Time
Code List
Time you took the study drug
CL Item
AM (1)
CL Item
PM (2)
Migraine Disorder, Pain, End Date
Item
Date your migraine headache pain stopped
date
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Migraine Disorder, Pain, End time
Item
Time your migraine headache pain stopped
time
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Time your migraine headache pain stopped
text
C0149931 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Migraine Disorder, Pain, End time
Code List
Time your migraine headache pain stopped
CL Item
AM (1)
CL Item
PM (2)
Item Group
Medications Taken Diary
C0013227 (UMLS CUI-1)
C3890583 (UMLS CUI-2)
Pharmaceutical Preparations, Subject Diary, Medication name
Item
Drug Name
text
C0013227 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Pharmaceutical Preparations, Subject Diary, Date in time, Taken
Item
Date Taken
date
C0013227 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Pharmaceutical Preparations, Subject Diary, Time, Taken
Item
Time Taken
time
C0013227 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Item
Time Taken
text
C0013227 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
Pharmaceutical Preparations, Subject Diary, Time, Taken
Code List
Time Taken
CL Item
AM (1)
CL Item
PM (2)
Item Group
Blood Pressure / Exercise / Migraine Headache Pain Information
C0005823 (UMLS CUI-1)
C0015259 (UMLS CUI-2)
C014993 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
Blood pressure measurement, Date in time
Item
Date Blood Pressure Measurements Taken
date
C3826646 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Time Blood Pressure Measurements Taken
text
C3826646 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure measurement, Time
Code List
Time Blood Pressure Measurements Taken
CL Item
AM (1)
CL Item
PM (2)
Blood pressure measurement, Exercise, Before
Item
Did you exercise in the 30 minutes before your blood pressure measurements were taken?
boolean
C3826646 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Indicate the intensity of any migraine headache pain you had at the time you took your blood pressure measurements.
text
C3826646 (UMLS CUI [1,1])
C0149931 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Blood pressure measurement, Migraine Disorders, Symptom intensity
Code List
Indicate the intensity of any migraine headache pain you had at the time you took your blood pressure measurements.
CL Item
None  (1)
CL Item
Mild  (2)
CL Item
Moderate  (3)
CL Item
Severe (4)
Item Group
Alcohol Use Diary
C0001948 (UMLS CUI-1)
C3890583 (UMLS CUI-2)
Alcohol consumption, Before, Blood pressure measurement
Item
Did you consume alcohol in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
boolean
C0001948 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C3826646 (UMLS CUI [1,3])
Alcohol consumption, Units, Numbers
Item
Number of Units
integer
C0001948 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Alcohol consumption, Date in time
Item
Date Consumed
date
C0001948 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Alcohol consumption, Time
Item
Time Consumed
time
C0001948 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time Consumed
text
C0001948 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Alcohol consumption, Time
Code List
Time Consumed
CL Item
AM (1)
CL Item
PM (2)
Item Group
Caffeine Use Diary
C2006086 (UMLS CUI-1)
C3890583 (UMLS CUI-2)
Caffeine Use, Before, Blood pressure measurement
Item
Did you consume caffeine in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
text
C2006086 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C3826646 (UMLS CUI [1,3])
Caffeine Use, Units, Numbers
Item
Number of Units
integer
C2006086 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Caffeine Use, Date in time
Item
Date Consumed
date
C2006086 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Caffeine Use, Time
Item
Time Consumed
time
C2006086 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time Consumed
text
C2006086 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Alcohol consumption, Time
Code List
Time Consumed
CL Item
AM (1)
CL Item
PM (2)
Item Group
Smoking/Tobacco Use Diary
C0543414 (UMLS CUI-1)
C3890583 (UMLS CUI-2)
Tobacco Use, Before, Blood pressure measurement
Item
Did you smoke and/or use tobacco in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
text
C0543414 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C3826646 (UMLS CUI [1,3])
Tobacco Use, Units, Numbers
Item
Number of Units
integer
C0543414 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Tobacco Use, Date in time
Item
Date Consumed
date
C0543414 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Tobacco Use, Time
Item
Time Consumed
time
C0543414 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time Consumed
text
C0543414 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Alcohol consumption, Time
Code List
Time Consumed
CL Item
AM (1)
CL Item
PM (2)
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