ID

44092

Beschreibung

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Week 12 - Visit 11 or Early Withdrawal.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Stichworte

Versionen (2)
  1. 19.04.18 19.04.18 - Sarah Riepenhausen
  2. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

Englisch

Week 12 - Visit 11 or Early Withdrawal

1 Formulare  
Early Withdrawal
Beschreibung

Early Withdrawal

Alias
UMLS CUI-1
C1710677
Which visit is the subject completing?
Beschreibung

Visit type

Datentyp

text

Alias
UMLS CUI [1]
C3641100
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschreibung

If assessments are taken on 2 separate dates for this visit, the Visit Date is the first date the subject is seen.

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0518766
Subject Position
Beschreibung

Record both; record sitting heart rate and blood pressure prior to recording standing heart rate and blood pressure.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Systolic Blood Pressure
Beschreibung

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Hair and skin
Beschreibung

Hair and skin

Datentyp

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
Hair and Skin: If Abnormal, please specify
Beschreibung

Hair and Skin

Datentyp

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
UMLS CUI [1,3]
C1704258
Lymph nodes
Beschreibung

Lymph nodes

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
Lymph nodes: If Abnormal, please specify
Beschreibung

Lymph nodes

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
UMLS CUI [1,3]
C1704258
Eyes
Beschreibung

Eyes

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0200149
Eyes: If Abnormal, please specify
Beschreibung

Eyes

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0200149
UMLS CUI [1,3]
C1704258
Ears, Nose and Throat
Beschreibung

Ears, Nose and Throat

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
Ears, Nose and Throat: If Abnormal, please specify
Beschreibung

Ears, Nose and Throat

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
UMLS CUI [1,3]
C1704258
Breasts
Beschreibung

Breasts

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
Breasts: If Abnormal, please specify
Beschreibung

Breasts

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
UMLS CUI [1,3]
C1704258
Respiratory
Beschreibung

Respiratory

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0436121
Respiratory: If Abnormal, please specify
Beschreibung

Respiratory

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0436121
UMLS CUI [1,3]
C1704258
Cardiovascular
Beschreibung

Cardiovascular

Datentyp

text

Alias
UMLS CUI [1]
C3854344
Cardiovascular: If Abnormal, please specify
Beschreibung

Cardiovascular

Datentyp

text

Alias
UMLS CUI [1,1]
C3854344
UMLS CUI [1,2]
C1704258
Abdomen
Beschreibung

Abdomen

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Abdomen: If Abnormal, please specify
Beschreibung

Abdomen

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C1704258
Urogenital
Beschreibung

Urogenital

Datentyp

text

Alias
UMLS CUI [1]
C1828035
Urogenital: If abnormal, please specify
Beschreibung

Urogenital

Datentyp

text

Alias
UMLS CUI [1,1]
C1828035
UMLS CUI [1,2]
C1704258
Pelvic
Beschreibung

Pelvic

Datentyp

text

Alias
UMLS CUI [1]
C0200045
Pelvic: If Abnormal, please specify
Beschreibung

Pelvic

Datentyp

text

Alias
UMLS CUI [1,1]
C0200045
UMLS CUI [1,2]
C1704258
Rectal
Beschreibung

Rectal

Datentyp

text

Alias
UMLS CUI [1]
C0199900
Rectal: If abnormal, please specify
Beschreibung

Rectal

Datentyp

text

Alias
UMLS CUI [1,1]
C0199900
UMLS CUI [1,2]
C1704258
Musculoskeletal
Beschreibung

Musculoskeletal

Datentyp

text

Alias
UMLS CUI [1]
C0475091
Musculoskeletal: If Abnormal, please specify
Beschreibung

Musculoskeletal

Datentyp

text

Alias
UMLS CUI [1,1]
C0475091
UMLS CUI [1,2]
C1704258
Neurological
Beschreibung

Neurological

Datentyp

text

Alias
UMLS CUI [1]
C0027853
Neurological: If Abnormal, please specify
Beschreibung

Neurological

Datentyp

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C1704258
Mental status
Beschreibung

Mental status

Datentyp

text

Alias
UMLS CUI [1]
C3260990
Mental Status: If Abnormal, please specify
Beschreibung

Mental Status

Datentyp

text

Alias
UMLS CUI [1,1]
C3260990
UMLS CUI [1,2]
C1704258
Psychiatric Evaluation
Beschreibung

Psychiatric Evaluation

Alias
UMLS CUI-1
C0846574
Total Score in Positive and Negative Syndrome Scale (PANSS)
Beschreibung

Positive and Negative Syndrome Scale (PANSS)

Datentyp

integer

Alias
UMLS CUI [1]
C0451383
Positive Scale Score in Positive and Negative Syndrome Scale (PANSS)
Beschreibung

Positive and Negative Syndrome Scale (PANSS) - Positive Scale

Datentyp

integer

Alias
UMLS CUI [1]
C0451383
Negative Scale Score in Positive and Negative Syndrome Scale (PANSS)
Beschreibung

Positive and Negative Syndrome Scale (PANSS) - Negative Scale

Datentyp

integer

Alias
UMLS CUI [1]
C0451383
General Psychopathology Score in Positive and Negative Syndrome Scale (PANSS)
Beschreibung

Positive and Negative Syndrome Scale (PANSS) - General Psychopathology

Datentyp

integer

Alias
UMLS CUI [1]
C0451383
Total score of "Scale for the Assessment of Negative Symptoms"
Beschreibung

5 Subdomains: Affective Flattening or Blunting Alogia Avolition - Apathy Anhedonia - Asociality Attention

Datentyp

integer

Alias
UMLS CUI [1,1]
C4511599
UMLS CUI [1,2]
C0681889
UMLS CUI [1,3]
C0036341
Score of "Calgary Depression Scale for Schizophrenia"
Beschreibung

Calgary Depression Scale for Schizophrenia (CDSS)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0679604
UMLS CUI [1,2]
C0036341
Score of Clinicians Global Impressions, Part Severity (CGI-S)
Beschreibung

Clinicians Global Impressions - Severity (CGI-S)

Datentyp

integer

Alias
UMLS CUI [1]
C3639887
Score of Clinicians Global Impressions, Part Improvement (CGI-I)
Beschreibung

Clinicians Global Impressions - Improvement (CGI-I)

Datentyp

integer

Alias
UMLS CUI [1]
C3639888
Score of "Brief Assessment of Cognition for Schizophrenia"
Beschreibung

Brief Assessment of Cognition for Schizophrenia (BACS)

Datentyp

integer

Alias
UMLS CUI [1]
C4055347
Score of "Simpson Angus Scale"
Beschreibung

Simpson Angus Scale

Datentyp

integer

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0015371
Score of "Barnes Akathisia Scale"
Beschreibung

The Barnes Akathisia Scale

Datentyp

integer

Alias
UMLS CUI [1]
C3541345
Score of "Abnormal Involuntary Movement Scale"
Beschreibung

Abnormal Involuntary Movement Scale (AIMS)

Datentyp

integer

Alias
UMLS CUI [1]
C0450978
Pharmacokinetic Sampling
Beschreibung

Pharmacokinetic Sampling

Sampling Date
Beschreibung

Sample No.: BLD006

Datentyp

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0201734
Sampling TIme
Beschreibung

Sampling Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0201734
Blood Sample taken?
Beschreibung

Sample No.: BLD006

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0201734
Atypical Antipsychotic Dosing
Beschreibung

Atypical Antipsychotic Dosing

Alias
UMLS CUI-1
C0040615
UMLS CUI-2
C0205182
UMLS CUI-3
C0178602
Drug Name
Beschreibung

Drug Name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C1276996
Was this atypical antipsychotic medication taken?
Beschreibung

Taking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1290952
UMLS CUI [1,2]
C1276996
Date dose taken
Beschreibung

Date dose taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1276996
Time dose taken
Beschreibung

Time dose taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1276996
Quality of Life Assessment
Beschreibung

Quality of Life Assessment

Alias
UMLS CUI-1
C0034380
Score of SF-36
Beschreibung

SF-36

Datentyp

integer

Alias
UMLS CUI [1]
C1519136
Score of "WHO (five) Well-Being Index"
Beschreibung

WHO (five) Well-Being Index

Datentyp

integer

Alias
UMLS CUI [1]
C3813622
Investigational Product Dosing
Beschreibung

Investigational Product Dosing

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0678766
Date dose taken
Beschreibung

Planned relative time: Day before Clinic Visit

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013227
Time dose taken
Beschreibung

Time dose taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
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Ähnliche Modelle

Week 12 - Visit 11 or Early Withdrawal

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Early Withdrawal
C1710677 (UMLS CUI-1)
Item
Which visit is the subject completing?
text
C3641100 (UMLS CUI [1])
Visit type
Code List
Which visit is the subject completing?
CL Item
Week 12 (C)
CL Item
Early withdrawal (W)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Item
Subject Position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject Position
Code List
Subject Position
CL Item
Sitting (1)
CL Item
Standing (2)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Hair and skin
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
Hair and skin
Code List
Hair and skin
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Hair and Skin
Item
Hair and Skin: If Abnormal, please specify
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Lymph nodes
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Hair and skin
Code List
Lymph nodes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Lymph nodes
Item
Lymph nodes: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Eyes
text
C0031809 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
Hair and skin
Code List
Eyes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Eyes
Item
Eyes: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Ears, Nose and Throat
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
Hair and skin
Code List
Ears, Nose and Throat
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Ears, Nose and Throat
Item
Ears, Nose and Throat: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Breasts
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
Breasts
Code List
Breasts
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Breasts
Item
Breasts: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Respiratory
text
C0031809 (UMLS CUI [1,1])
C0436121 (UMLS CUI [1,2])
Hair and skin
Code List
Respiratory
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Respiratory
Item
Respiratory: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0436121 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Cardiovascular
text
C3854344 (UMLS CUI [1])
Hair and skin
Code List
Cardiovascular
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Cardiovascular
Item
Cardiovascular: If Abnormal, please specify
text
C3854344 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Abdomen
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Hair and skin
Code List
Abdomen
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abdomen
Item
Abdomen: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Urogenital
text
C1828035 (UMLS CUI [1])
Urogenital
Code List
Urogenital
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Urogenital
Item
Urogenital: If abnormal, please specify
text
C1828035 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Pelvic
text
C0200045 (UMLS CUI [1])
Breasts
Code List
Pelvic
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Pelvic
Item
Pelvic: If Abnormal, please specify
text
C0200045 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Rectal
text
C0199900 (UMLS CUI [1])
Breasts
Code List
Rectal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Rectal
Item
Rectal: If abnormal, please specify
text
C0199900 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Musculoskeletal
text
C0475091 (UMLS CUI [1])
Lymph nodes
Code List
Musculoskeletal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Musculoskeletal
Item
Musculoskeletal: If Abnormal, please specify
text
C0475091 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Neurological
text
C0027853 (UMLS CUI [1])
Hair and skin
Code List
Neurological
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Neurological
Item
Neurological: If Abnormal, please specify
text
C0027853 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Mental status
text
C3260990 (UMLS CUI [1])
Hair and skin
Code List
Mental status
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Mental Status
Item
Mental Status: If Abnormal, please specify
text
C3260990 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Psychiatric Evaluation
C0846574 (UMLS CUI-1)
Positive and Negative Syndrome Scale (PANSS)
Item
Total Score in Positive and Negative Syndrome Scale (PANSS)
integer
C0451383 (UMLS CUI [1])
Positive and Negative Syndrome Scale (PANSS) - Positive Scale
Item
Positive Scale Score in Positive and Negative Syndrome Scale (PANSS)
integer
C0451383 (UMLS CUI [1])
Positive and Negative Syndrome Scale (PANSS) - Negative Scale
Item
Negative Scale Score in Positive and Negative Syndrome Scale (PANSS)
integer
C0451383 (UMLS CUI [1])
Positive and Negative Syndrome Scale (PANSS) - General Psychopathology
Item
General Psychopathology Score in Positive and Negative Syndrome Scale (PANSS)
integer
C0451383 (UMLS CUI [1])
Scale for the Assessment of Negative Symptoms (SANS)
Item
Total score of "Scale for the Assessment of Negative Symptoms"
integer
C4511599 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Calgary Depression Scale for Schizophrenia (CDSS)
Item
Score of "Calgary Depression Scale for Schizophrenia"
integer
C0679604 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
Clinicians Global Impressions - Severity (CGI-S)
Item
Score of Clinicians Global Impressions, Part Severity (CGI-S)
integer
C3639887 (UMLS CUI [1])
Clinicians Global Impressions - Improvement (CGI-I)
Item
Score of Clinicians Global Impressions, Part Improvement (CGI-I)
integer
C3639888 (UMLS CUI [1])
Brief Assessment of Cognition for Schizophrenia (BACS)
Item
Score of "Brief Assessment of Cognition for Schizophrenia"
integer
C4055347 (UMLS CUI [1])
Simpson Angus Scale
Item
Score of "Simpson Angus Scale"
integer
C0681889 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0015371 (UMLS CUI [1,3])
The Barnes Akathisia Scale
Item
Score of "Barnes Akathisia Scale"
integer
C3541345 (UMLS CUI [1])
Abnormal Involuntary Movement Scale (AIMS)
Item
Score of "Abnormal Involuntary Movement Scale"
integer
C0450978 (UMLS CUI [1])
Item Group
Pharmacokinetic Sampling
Sampling Date
Item
Sampling Date
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
Sampling Time
Item
Sampling TIme
time
C0040223 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
Blood Sample
Item
Blood Sample taken?
boolean
C0005834 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Item Group
Atypical Antipsychotic Dosing
C0040615 (UMLS CUI-1)
C0205182 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C1276996 (UMLS CUI [1,2])
Drug Name
Code List
Drug Name
CL Item
Abilify (aripiprazole) (Abilify (aripiprazole))
CL Item
Clozaril (clozapine) (Clozaril (clozapine))
CL Item
Geodon (ziprasidone) (Geodon (ziprasidone))
CL Item
Risperdal (risperidone) (Risperdal (risperidone))
CL Item
Seroquel (quetiapine fumarate) (Seroquel (quetiapine fumarate))
CL Item
Zyprexa/Zydis (olanzapine) (Zyprexa/Zydis (olanzapine))
Taking
Item
Was this atypical antipsychotic medication taken?
boolean
C1290952 (UMLS CUI [1,1])
C1276996 (UMLS CUI [1,2])
Date dose taken
Item
Date dose taken
date
C0011008 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1276996 (UMLS CUI [1,3])
Time dose taken
Item
Time dose taken
time
C0040223 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1276996 (UMLS CUI [1,3])
Item Group
Quality of Life Assessment
C0034380 (UMLS CUI-1)
SF-36
Item
Score of SF-36
integer
C1519136 (UMLS CUI [1])
WHO (five) Well-Being Index
Item
Score of "WHO (five) Well-Being Index"
integer
C3813622 (UMLS CUI [1])
Item Group
Investigational Product Dosing
C0304229 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
Date dose taken
Item
Date dose taken
date
C0011008 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Time dose taken
Item
Time dose taken
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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