ID

41015

Description

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Keywords

Versions (1)
  1. 6/12/20 6/12/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 12, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447

English

Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Check one

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1]
C3841890
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0012634
Diagnosis
Description

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Data type

text

Alias
UMLS CUI [1]
C0011900
Medical condition status
Description

Medical condition status

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Alcohol intake
Description

Alcohol intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Description

Does the subject consume alcohol?

Data type

boolean

Alias
UMLS CUI [1]
C0001948
If subject consumes alcohol, record the average number of units of alcohol consumed per week
Description

If subject consumes alcohol, record the average number of units of alcohol1 consumed per week

Data type

integer

Measurement units
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
History of Tobacco Use
Description

History of Tobacco Use

Alias
UMLS CUI-1
C0841002
What is the subject’s history of tobacco use (includes all tobacco products)?
Description

What is the subject’s history of tobacco use (includes all tobacco products)?

Data type

integer

Alias
UMLS CUI [1]
C0841002
If former smoker, when did the subject last smoke/ use tobacco?
Description

If former smoker, when did the subject last smoke/ use tobacco?

Data type

date

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C0037369
UMLS CUI [1,3]
C1517741
If current or former smoker, record average number of cigarettes smoked per day
Description

If current or former smoker, record average number of cigarettes smoked per day

Data type

integer

Measurement units
  • cigarettes per day
Alias
UMLS CUI [1]
C0337671
UMLS CUI [2]
C0037369
UMLS CUI [3]
C3694146
cigarettes per day
If current or former smoker, record number of years during which the subject has smoked/used tobacco
Description

If current or former smoker, record number of years during which the subject has smoked/used tobacco

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1]
C0337671
UMLS CUI [2]
C0037369
UMLS CUI [3,1]
C0037369
UMLS CUI [3,2]
C0439234
UMLS CUI [3,3]
C0449788
years
If current or former smoker, record number of pack years
Description

If current or former smoker, record number of pack years

Data type

integer

Measurement units
  • pack years
Alias
UMLS CUI [1]
C0337671
UMLS CUI [2]
C0037369
UMLS CUI [3]
C1277691
pack years
Is the subject currently using a nicotine oral regimen or topical application (e.g., gum, patches, etc.)?
Description

Is the subject currently using a nicotine oral regimen or topical application (e.g., gum, patches, etc.)?

Data type

boolean

Alias
UMLS CUI [1,1]
C1270916
UMLS CUI [1,2]
C3213077
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Similar models

Screening - Demography; Medical Conditions; Alcohol Intake; History of Tobacco Use

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
integer
C3841890 (UMLS CUI [1])
Geographic Ancestry
Code List
Geographic Ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Medical condition status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Medical condition status
Code List
Medical condition status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
If subject consumes alcohol, record the average number of units of alcohol1 consumed per week
Item
If subject consumes alcohol, record the average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
History of Tobacco Use
C0841002 (UMLS CUI-1)
Item
What is the subject’s history of tobacco use (includes all tobacco products)?
integer
C0841002 (UMLS CUI [1])
What is the subject’s history of tobacco use (includes all tobacco products)?
Code List
What is the subject’s history of tobacco use (includes all tobacco products)?
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
If former smoker, when did the subject last smoke/ use tobacco?
Item
If former smoker, when did the subject last smoke/ use tobacco?
date
C0337671 (UMLS CUI [1,1])
C0037369 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
If current or former smoker, record average number of cigarettes smoked per day
Item
If current or former smoker, record average number of cigarettes smoked per day
integer
C0337671 (UMLS CUI [1])
C0037369 (UMLS CUI [2])
C3694146 (UMLS CUI [3])
If current or former smoker, record number of years during which the subject has smoked/used tobacco
Item
If current or former smoker, record number of years during which the subject has smoked/used tobacco
integer
C0337671 (UMLS CUI [1])
C0037369 (UMLS CUI [2])
C0037369 (UMLS CUI [3,1])
C0439234 (UMLS CUI [3,2])
C0449788 (UMLS CUI [3,3])
If current or former smoker, record number of pack years
Item
If current or former smoker, record number of pack years
integer
C0337671 (UMLS CUI [1])
C0037369 (UMLS CUI [2])
C1277691 (UMLS CUI [3])
Is the subject currently using a nicotine oral regimen or topical application (e.g., gum, patches, etc.)?
Item
Is the subject currently using a nicotine oral regimen or topical application (e.g., gum, patches, etc.)?
boolean
C1270916 (UMLS CUI [1,1])
C3213077 (UMLS CUI [1,2])
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