ID

41096

Beschrijving

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

Trefwoorden

Versies (1)
  1. 23-06-20 23-06-20 -
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GlaxoSmithKline

Geüploaded op

23 juni 2020

DOI

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Licentie

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

Engels

Study Conclusion; Pregnancy Information; Investigator Comment Log, Investigator's Signature

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study Conclusion
Beschrijving

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Beschrijving

Date of subject completion or withdrawal

Datatype

date

Alias
UMLS CUI [1]
C2983670
Time of withdrawal
Beschrijving

Time of withdrawal

Datatype

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Was the subject withdrawn from the study?
Beschrijving

Was the subject withdrawn from the study?

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Beschrijving

Primary reason for withdrawal

Datatype

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If other reason for withdrawal, specify
Beschrijving

If other reason for withdrawal, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Pregnancy Information
Beschrijving

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschrijving

If Yes, complete Pregnancy Notification form.

Datatype

text

Alias
UMLS CUI [1]
C3828490
Did a female partner of the male subject become pregnant during the study?
Beschrijving

If Yes, complete Pregnancy Notification form.

Datatype

text

Alias
UMLS CUI [1]
C0919624
Investigator Comment Log
Beschrijving

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number if applicable
Beschrijving

CRF page number if applicable

Datatype

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Investigator's Signature
Beschrijving

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Beschrijving

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator’s name
Beschrijving

Investigator’s name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Investigator's Signature Date
Beschrijving

Investigator's Signature Date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study Conclusion; Pregnancy Information; Investigator Comment Log, Investigator's Signature

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Time of withdrawal
Item
Time of withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse event (Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.) (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Disease progression (5)
CL Item
Death (Complete the Death page and if applicable, the SAE page(s).) (6)
CL Item
Other, specify (7)
If other reason for withdrawal, specify
Item
If other reason for withdrawal, specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Did the subject become pregnant during the study?
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (not of childbearing potential or male) (X)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Did a female partner of the male subject become pregnant during the study?
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (subject is female, female partner not of childbearing potential or no female partner) (X)
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number if applicable
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator’s name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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