ID
40996
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)
- 6/9/20 6/9/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 9, 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
Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
Description
Pregnancy Notification Form - Mother's relevant medical/ family history
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C0026591
- UMLS CUI-3
- C0262926
- UMLS CUI-4
- C0241889
Description
Mother’s date of birth
Data type
date
Alias
- UMLS CUI [1,1]
- C0421451
- UMLS CUI [1,2]
- C0026591
Description
Date of last menstrual period
Data type
date
Alias
- UMLS CUI [1]
- C0425932
Description
Estimated date of delivery
Data type
date
Alias
- UMLS CUI [1]
- C1287845
Description
Was the mother using a method of contraception?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0700589
Description
If the mother was using a method of contraception, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0700589
- UMLS CUI [1,3]
- C2348235
Description
Check one
Data type
integer
Alias
- UMLS CUI [1]
- C2598844
Description
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Data type
text
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C1456803
- UMLS CUI [3]
- C0002627
- UMLS CUI [4]
- C0008509
- UMLS CUI [5]
- C0011008
Description
Number of previous pregnancies - Pre-term
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C1547235
Description
Number of previous pregnancies - Full-term
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C3814420
Description
Number of previous pregnancies - Normal births
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C3665337
Description
Number of previous pregnancies - Stillbirths
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0595939
Description
Number of previous pregnancies - Children with birth defects
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0000768
Description
Number of previous pregnancies - Spontaneous abortion
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0000786
Description
Number of previous pregnancies - Elective abortion
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0269439
Description
Number of previous pregnancies - Other
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0205394
Description
Record details of children born with defects
Data type
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0000768
Description
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
Description
If there are any additional factors that may have an impact on the outcome of this pregnancy, specify.
Data type
text
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
- UMLS CUI [1,3]
- C2348235
Description
Pregnancy Notification Form - Father's relevant medical/ family history
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C0015671
- UMLS CUI-3
- C0262926
- UMLS CUI-4
- C0241889
Description
(Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic chromosomal disorders and medication use)
Data type
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0015671
- UMLS CUI [1,3]
- C0262926
- UMLS CUI [1,4]
- C0241889
Description
Pregnancy Notification Form - Drug Exposures
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C0743284
Description
Trade Name preferred
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Route of Administration or Formulation
Data type
text
Alias
- UMLS CUI [1]
- C0013153
- UMLS CUI [2]
- C1705957
Description
Total Daily Dose
Data type
float
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0439810
Description
Medication Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Medication started pre-study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0332152
- UMLS CUI [2,2]
- C2347804
Description
Medication start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Medication stop date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Ongoing medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Was the subject withdrawn from the study as a result of this pregnancy?
Data type
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
Reporting Investigator Information
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Description
Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Title
Data type
text
Alias
- UMLS CUI [1]
- C3888414
Description
Speciality
Data type
text
Alias
- UMLS CUI [1]
- C0037778
Description
Address
Data type
text
Alias
- UMLS CUI [1]
- C1442065
Description
City or State/Province
Data type
text
Alias
- UMLS CUI [1,1]
- C0008848
- UMLS CUI [1,2]
- C1547742
Description
Country
Data type
text
Alias
- UMLS CUI [1]
- C0454664
Description
Post or Zip Code
Data type
text
Alias
- UMLS CUI [1,1]
- C1514254
- UMLS CUI [1,2]
- C0600091
Description
Telephone No
Data type
integer
Alias
- UMLS CUI [1]
- C1515258
Description
Fax No
Data type
integer
Alias
- UMLS CUI [1]
- C1549619
Description
(confirming that the data on these pages are accurate and complete)
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator’s signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator’s name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0026591 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0241889 (UMLS CUI-4)
C0026591 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1456803 (UMLS CUI [2])
C0002627 (UMLS CUI [3])
C0008509 (UMLS CUI [4])
C0011008 (UMLS CUI [5])
C1547235 (UMLS CUI [1,2])
C3814420 (UMLS CUI [1,2])
C3665337 (UMLS CUI [1,2])
C0595939 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,2])
C0000786 (UMLS CUI [1,2])
C0269439 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0015671 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0241889 (UMLS CUI-4)
C0015671 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,4])
C0743284 (UMLS CUI-2)
C1705957 (UMLS CUI [2])
C0439810 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C1547742 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])