ID

32720

Description

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains eligibility determination. It has to be filled in at screening.

Mots-clés

Versions (1)
  1. 13/11/2018 13/11/2018 -
Détendeur de droits

GlaxoSmithKline

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13 novembre 2018

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Creative Commons BY-NC 3.0
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Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

Anglais

Eligibility criteria

1 Formulaires  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of screening
Description

Date of screening

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Has a signed and dated written informed consent been obtained prior to study participation?
Description

Written informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Is the subject aged 18-65 years (inclusive)?
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Does the subject have a Body Mass Index within the range of 19 to 30 kg.m-2 inclusive?
Description

BMI=weight kg/height m²

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
Is the subject male or an eligible female?
Description

Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
Does the subject have a history of asthma of at least 6 months duration, and has required treatment over the 6 months preceding screening?
Description

Asthma, required treatment

Type de données

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1514873
Does the subject have mild or intermittent asthma and has a best (maximum) screening peak expiratory flow (PEF) and Forced Expiratory Volume in 1 second (FEV1) of > 80% predicted after withholding all asthma edications for 6 hours?
Description

Mild/intermittent asthma, PEF, FEV1

Type de données

boolean

Alias
UMLS CUI [1,1]
C2945599
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C0205267
UMLS CUI [2,2]
C0004096
UMLS CUI [3,1]
C0521299
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C0748133
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0087111
Is the subject currently taking inhaled steroids ( up to 800mcg per day of BDP or equivalent but not FP), cromolyn, nedocromil, leukotriene modifiers, and/or albuterol/salbutamol, and has the subject remained on a fixed regimen for at least 4 weeks before screening?
Description

Current inhaled steroids (BDP or equivalent, not FP), cromolyn, nedocromil, leukotriene modifiers, and/or albuterol/salbutamol

Type de données

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C2065041
UMLS CUI [2,1]
C0004906
UMLS CUI [2,2]
C0205163
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C1298908
UMLS CUI [3,2]
C0683607
UMLS CUI [3,3]
C0082607
UMLS CUI [4]
C0086073
UMLS CUI [5]
C0068483
UMLS CUI [6]
C0595726
UMLS CUI [7]
C0001927
Is the subject a lifetime non-smoker or an ex-smoker of >1 year duration with a <5 year pack history?
Description

Lifetime non-smoker, ex-smoker

Type de données

boolean

Alias
UMLS CUI [1,1]
C4071830
UMLS CUI [1,2]
C0337672
UMLS CUI [2]
C0337671
With the exception of asthma, is the subject in good health (as shown by ECG, safety laboratory tests etc.)?
Description

Good health (shown by ECG, safety laboratory tests etc.)

Type de données

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2]
C1623258
UMLS CUI [3]
C0022885
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Is the subject currently taking any of the following: Oral corticosteroids or inhaled FP, Oral steroids (must have not been used within 4 weeks prior to the Screening Visit and if used during the course of the study should result in subject withdrawal), Intranasal or topical FP (must be excluded within two weeks before Screening Visit and during the study).
Description

Oral corticosteroids, inhaled FP, oral steroids, intranasal/topical FP

Type de données

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0205535
UMLS CUI [2,2]
C0082607
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0304604
UMLS CUI [4,2]
C0082607
Has the subject been exposed to an investigational drug/placebo within 30 days prior to Visit 1 or within 5 half-lives (t1/2) of the prior investigational product (whichever is the longer of the two)?
Description

Exposition to an investigational drug/placebo

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0681324
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C0681324
UMLS CUI [2,3]
C0032042
Is there any historical or current evidence of significant diseases including, but not limited to those listed below: Other significant pulmonary disease including cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia; Respiratory tract infection within 4 weeks prior to screening; Clinical or radiological evidence of pneumonia within the preceding 3 months (Radiographs are not required.); Disorders of the ears, nose, throat or sinuses likely to require surgical intervention during the study treatment period; Cardiovascular disease; Endocrine disorders; Renal disease; Hepatic disease; Disorder of cellular or humoral immunity; Malignancy
Description

Significant is defined as any disease that in the opinion of the investigator would put the subject at risk through study participation or which would affect the pharmacokinetic analysis if the disease exacerbated during the study.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0750502
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0010674
UMLS CUI [4]
C0006267
UMLS CUI [5]
C0006287
UMLS CUI [6]
C0035243
UMLS CUI [7]
C0032285
UMLS CUI [8]
C0395797
UMLS CUI [9]
C0007222
UMLS CUI [10]
C0014130
UMLS CUI [11]
C0022658
UMLS CUI [12]
C0023895
UMLS CUI [13,1]
C1513041
UMLS CUI [13,2]
C0020967
UMLS CUI [14,1]
C1513041
UMLS CUI [14,2]
C0020966
UMLS CUI [15]
C0006826
Does the subject have any immediate or delayed hypersensitivity to any sympathomimetic drug or any intranasal, inhaled or systemic corticosteroid therapy?
Description

Hypersensitivity to sympathomimetic drug/intranasal, inhaled or systemic corticosteroid

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002509
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0304604
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2065041
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C4053960
Does the subject have a history of severe milk protein (lactose) allergy?
Description

Severe milk protein (lactose) allergy

Type de données

boolean

Alias
UMLS CUI [1]
C0022951
UMLS CUI [2]
C3889086
Does the subject have a history of drug or alcohol abuse?
Description

Drug or alcohol abuse

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0085762
Does the subject have a positive urine drug screen (UDS) including alcohol at screening?
Description

Positive urine drug screen including alcohol

Type de données

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0202304
Does the subject have a positive hepatitis B virus, hepatitis C virus or HIV test at screening?
Description

Positive hepatitis B virus, hepatitis C virus, HIV

Type de données

boolean

Alias
UMLS CUI [1,1]
C1446409
UMLS CUI [1,2]
C0019169
UMLS CUI [2,1]
C1446409
UMLS CUI [2,2]
C0220847
UMLS CUI [3]
C0019699
Does the subject have a positive serum beta-human chorionic gonadotropin (b-hCG) test (females)?
Description

Positive serum beta-human chorionic gonadotropin (b-hCG) test

Type de données

boolean

Alias
UMLS CUI [1,1]
C1255526
UMLS CUI [1,2]
C1446409
Is the subject a pregnant or nursing females or a female of childbearing potential who is unwilling or unable to use an appropriate method of contraception from at least 14 days prior to first dose of study medication administration until completion of follow-up procedures?
Description

Pregnancy, nursing, childbearing potential, unwilling to use a method of contraception

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4,1]
C0558080
UMLS CUI [4,2]
C1524063
UMLS CUI [4,3]
C0700589
Has the subject donated blood in excess of 500millilitres (mL) within 56 days prior to first dose of study medication?
Description

Blood donation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C0205435
Does the subject have a history of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof?
Description

Sensitivity to heparin, heparin-induced thrombocytopenia, study medications

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0019134
UMLS CUI [2]
C0272285
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0304229
Is the subject a current smokers or has the subject smoked within the last year or have a >5 year pack history?
Description

Current smoker

Type de données

boolean

Alias
UMLS CUI [1]
C3241966
Has the subject used prescription or non-prescription drugs (with the exception of permitted asthma medication previously mentioned), including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of the study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise study safety? Subjects taking ritonavir should not be included in this study.
Description

Prescription or non-prescription drugs (vitamins, herbal,dietary supplements), ritonavir not allowed

Type de données

boolean

Alias
UMLS CUI [1]
C0304227
UMLS CUI [2]
C0013231
UMLS CUI [3]
C0042890
UMLS CUI [4]
C0025125
UMLS CUI [5]
C0242295
UMLS CUI [6]
C0936242
UMLS CUI [7,1]
C0292818
UMLS CUI [7,2]
C1298908
UMLS CUI [7,3]
C0683607
Inclusion / Exclusion Criteria
Description

Inclusion / Exclusion Criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C1512693
Did the subject meet all entry criteria?
Description

(i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria). Tick all boxes that represent a violation of the inclusion / exclusion criteria below.

Type de données

text

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

Type de données

integer

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Description

Exclusion Criteria

Type de données

integer

Alias
UMLS CUI [1]
C0680251
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Similar models

Eligibility criteria

1 Formulaires
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of screening
Item
Date of screening
date
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Written informed consent
Item
Has a signed and dated written informed consent been obtained prior to study participation?
boolean
C0021430 (UMLS CUI [1])
Age
Item
Is the subject aged 18-65 years (inclusive)?
boolean
C0001779 (UMLS CUI [1])
BMI
Item
Does the subject have a Body Mass Index within the range of 19 to 30 kg.m-2 inclusive?
boolean
C1305855 (UMLS CUI [1])
Gender
Item
Is the subject male or an eligible female?
boolean
C0079399 (UMLS CUI [1])
Asthma, required treatment
Item
Does the subject have a history of asthma of at least 6 months duration, and has required treatment over the 6 months preceding screening?
boolean
C0004096 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Mild/intermittent asthma, PEF, FEV1
Item
Does the subject have mild or intermittent asthma and has a best (maximum) screening peak expiratory flow (PEF) and Forced Expiratory Volume in 1 second (FEV1) of > 80% predicted after withholding all asthma edications for 6 hours?
boolean
C2945599 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0205267 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0521299 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0748133 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
Current inhaled steroids (BDP or equivalent, not FP), cromolyn, nedocromil, leukotriene modifiers, and/or albuterol/salbutamol
Item
Is the subject currently taking inhaled steroids ( up to 800mcg per day of BDP or equivalent but not FP), cromolyn, nedocromil, leukotriene modifiers, and/or albuterol/salbutamol, and has the subject remained on a fixed regimen for at least 4 weeks before screening?
boolean
C0521116 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C0004906 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C1298908 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0082607 (UMLS CUI [3,3])
C0086073 (UMLS CUI [4])
C0068483 (UMLS CUI [5])
C0595726 (UMLS CUI [6])
C0001927 (UMLS CUI [7])
Lifetime non-smoker, ex-smoker
Item
Is the subject a lifetime non-smoker or an ex-smoker of >1 year duration with a <5 year pack history?
boolean
C4071830 (UMLS CUI [1,1])
C0337672 (UMLS CUI [1,2])
C0337671 (UMLS CUI [2])
Good health (shown by ECG, safety laboratory tests etc.)
Item
With the exception of asthma, is the subject in good health (as shown by ECG, safety laboratory tests etc.)?
boolean
C1277245 (UMLS CUI [1])
C1623258 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Oral corticosteroids, inhaled FP, oral steroids, intranasal/topical FP
Item
Is the subject currently taking any of the following: Oral corticosteroids or inhaled FP, Oral steroids (must have not been used within 4 weeks prior to the Screening Visit and if used during the course of the study should result in subject withdrawal), Intranasal or topical FP (must be excluded within two weeks before Screening Visit and during the study).
boolean
C0001617 (UMLS CUI [1])
C0205535 (UMLS CUI [2,1])
C0082607 (UMLS CUI [2,2])
C0038317 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0304604 (UMLS CUI [4,1])
C0082607 (UMLS CUI [4,2])
Exposition to an investigational drug/placebo
Item
Has the subject been exposed to an investigational drug/placebo within 30 days prior to Visit 1 or within 5 half-lives (t1/2) of the prior investigational product (whichever is the longer of the two)?
boolean
C0205156 (UMLS CUI [1,1])
C0681324 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0205156 (UMLS CUI [2,1])
C0681324 (UMLS CUI [2,2])
C0032042 (UMLS CUI [2,3])
Significant diseases (pulmonary disease like cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia; Respiratory tract infection; Pneumonia; disorder of ears, nose, throat, sinuses; Cardiovascular disease; Endocrine disorders; Renal disease; Hepatic disease; Disorder of cellular or humoral immunity; Malignancy)
Item
Is there any historical or current evidence of significant diseases including, but not limited to those listed below: Other significant pulmonary disease including cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia; Respiratory tract infection within 4 weeks prior to screening; Clinical or radiological evidence of pneumonia within the preceding 3 months (Radiographs are not required.); Disorders of the ears, nose, throat or sinuses likely to require surgical intervention during the study treatment period; Cardiovascular disease; Endocrine disorders; Renal disease; Hepatic disease; Disorder of cellular or humoral immunity; Malignancy
boolean
C0750502 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
C0006267 (UMLS CUI [4])
C0006287 (UMLS CUI [5])
C0035243 (UMLS CUI [6])
C0032285 (UMLS CUI [7])
C0395797 (UMLS CUI [8])
C0007222 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0022658 (UMLS CUI [11])
C0023895 (UMLS CUI [12])
C1513041 (UMLS CUI [13,1])
C0020967 (UMLS CUI [13,2])
C1513041 (UMLS CUI [14,1])
C0020966 (UMLS CUI [14,2])
C0006826 (UMLS CUI [15])
Hypersensitivity to sympathomimetic drug/intranasal, inhaled or systemic corticosteroid
Item
Does the subject have any immediate or delayed hypersensitivity to any sympathomimetic drug or any intranasal, inhaled or systemic corticosteroid therapy?
boolean
C0020517 (UMLS CUI [1,1])
C0002509 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304604 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C4053960 (UMLS CUI [4,2])
Severe milk protein (lactose) allergy
Item
Does the subject have a history of severe milk protein (lactose) allergy?
boolean
C0022951 (UMLS CUI [1])
C3889086 (UMLS CUI [2])
Drug or alcohol abuse
Item
Does the subject have a history of drug or alcohol abuse?
boolean
C0038586 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Positive urine drug screen including alcohol
Item
Does the subject have a positive urine drug screen (UDS) including alcohol at screening?
boolean
C0743300 (UMLS CUI [1])
C0202304 (UMLS CUI [2])
Positive hepatitis B virus, hepatitis C virus, HIV
Item
Does the subject have a positive hepatitis B virus, hepatitis C virus or HIV test at screening?
boolean
C1446409 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C1446409 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3])
Positive serum beta-human chorionic gonadotropin (b-hCG) test
Item
Does the subject have a positive serum beta-human chorionic gonadotropin (b-hCG) test (females)?
boolean
C1255526 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Pregnancy, nursing, childbearing potential, unwilling to use a method of contraception
Item
Is the subject a pregnant or nursing females or a female of childbearing potential who is unwilling or unable to use an appropriate method of contraception from at least 14 days prior to first dose of study medication administration until completion of follow-up procedures?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0558080 (UMLS CUI [4,1])
C1524063 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
Blood donation
Item
Has the subject donated blood in excess of 500millilitres (mL) within 56 days prior to first dose of study medication?
boolean
C0005794 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
Sensitivity to heparin, heparin-induced thrombocytopenia, study medications
Item
Does the subject have a history of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof?
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0304229 (UMLS CUI [3,2])
Current smoker
Item
Is the subject a current smokers or has the subject smoked within the last year or have a >5 year pack history?
boolean
C3241966 (UMLS CUI [1])
Prescription or non-prescription drugs (vitamins, herbal,dietary supplements), ritonavir not allowed
Item
Has the subject used prescription or non-prescription drugs (with the exception of permitted asthma medication previously mentioned), including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of the study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise study safety? Subjects taking ritonavir should not be included in this study.
boolean
C0304227 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C0025125 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
C0936242 (UMLS CUI [6])
C0292818 (UMLS CUI [7,1])
C1298908 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
Item Group
Inclusion / Exclusion Criteria
C0680251 (UMLS CUI-1)
C1512693 (UMLS CUI-2)
Item
Did the subject meet all entry criteria?
text
C1516637 (UMLS CUI [1])
Entry criteria
Code List
Did the subject meet all entry criteria?
CL Item
No (N)
CL Item
Yes (Y)
Item
Inclusion Criteria
integer
C1512693 (UMLS CUI [1])
Inclusion Criteria
Code List
Inclusion Criteria
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6  (6)
CL Item
7 (7)
CL Item
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