ID

41060

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. 6/17/20 6/17/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 17, 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

Continuous Holter ECG

1 forms  
  1. StudyEvent: ODM
    1. Continuous Holter ECG
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Predose Continuous 24 hour Holter ECG (Day1)
Description

Predose Continuous 24 hour Holter ECG (Day1)

Alias
UMLS CUI-1
C2046759
Start date of ECG
Description

Start date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Start time of ECG
Description

Start time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1301880
End date of ECG
Description

End date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0806020
End time of ECG
Description

End time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
Result of the ECG
Description

Check one

Data type

integer

Alias
UMLS CUI [1]
C0438154
Continuous 24 hour Holter ECG (Day3)
Description

Continuous 24 hour Holter ECG (Day3)

Alias
UMLS CUI-1
C2046759
Start date of ECG
Description

Start date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Start time of ECG
Description

Start time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1301880
End date of ECG
Description

End date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0806020
End time of ECG
Description

End time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
Result of the ECG
Description

Check one

Data type

integer

Alias
UMLS CUI [1]
C0438154
Continuous 48 hour Holter ECG (Day 5)
Description

Continuous 48 hour Holter ECG (Day 5)

Alias
UMLS CUI-1
C0013801
Start date of ECG
Description

Start date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Start time of ECG
Description

Start time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1301880
End date of ECG
Description

End date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0806020
End time of ECG
Description

End time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
Result of the ECG
Description

Check one

Data type

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

Continuous Holter ECG

1 forms
  1. StudyEvent: ODM
    1. Continuous Holter ECG
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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Predose Continuous 24 hour Holter ECG (Day1)
C2046759 (UMLS CUI-1)
Start date of ECG
Item
Start date of ECG
date
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Start time of ECG
Item
Start time of ECG
time
C1623258 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End date of ECG
Item
End date of ECG
date
C1623258 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End time of ECG
Item
End time of ECG
time
C1623258 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional ECG Abnormalities page if clinically significant abnormalities are present.) (3)
CL Item
No result (not available) (4)
Item Group
Continuous 24 hour Holter ECG (Day3)
C2046759 (UMLS CUI-1)
Start date of ECG
Item
Start date of ECG
date
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Start time of ECG
Item
Start time of ECG
time
C1623258 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End date of ECG
Item
End date of ECG
date
C1623258 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End time of ECG
Item
End time of ECG
time
C1623258 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional ECG Abnormalities page if clinically significant abnormalities are present.) (3)
CL Item
No result (not available) (4)
Item Group
Continuous 48 hour Holter ECG (Day 5)
C0013801 (UMLS CUI-1)
Start date of ECG
Item
Start date of ECG
date
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Start time of ECG
Item
Start time of ECG
time
C1623258 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End date of ECG
Item
End date of ECG
date
C1623258 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End time of ECG
Item
End time of ECG
time
C1623258 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional ECG Abnormalities page if clinically significant abnormalities are present.) (3)
CL Item
No result (not available) (4)
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