ID
40996
Beskrivning
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
Nyckelord
Versioner (1)
- 2020-06-09 2020-06-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
9 juni 2020
DOI
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Licens
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
Beskrivning
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
Beskrivning
Mother’s date of birth
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0421451
- UMLS CUI [1,2]
- C0026591
Beskrivning
Date of last menstrual period
Datatyp
date
Alias
- UMLS CUI [1]
- C0425932
Beskrivning
Estimated date of delivery
Datatyp
date
Alias
- UMLS CUI [1]
- C1287845
Beskrivning
Was the mother using a method of contraception?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0700589
Beskrivning
If the mother was using a method of contraception, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0700589
- UMLS CUI [1,3]
- C2348235
Beskrivning
Check one
Datatyp
integer
Alias
- UMLS CUI [1]
- C2598844
Beskrivning
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
- UMLS CUI [2]
- C1456803
- UMLS CUI [3]
- C0002627
- UMLS CUI [4]
- C0008509
- UMLS CUI [5]
- C0011008
Beskrivning
Number of previous pregnancies - Pre-term
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C1547235
Beskrivning
Number of previous pregnancies - Full-term
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C3814420
Beskrivning
Number of previous pregnancies - Normal births
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C3665337
Beskrivning
Number of previous pregnancies - Stillbirths
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0595939
Beskrivning
Number of previous pregnancies - Children with birth defects
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0000768
Beskrivning
Number of previous pregnancies - Spontaneous abortion
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0000786
Beskrivning
Number of previous pregnancies - Elective abortion
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0269439
Beskrivning
Number of previous pregnancies - Other
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0205394
Beskrivning
Record details of children born with defects
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0000768
Beskrivning
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
Beskrivning
If there are any additional factors that may have an impact on the outcome of this pregnancy, specify.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032972
- UMLS CUI [1,2]
- C1521761
- UMLS CUI [1,3]
- C2348235
Beskrivning
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
Beskrivning
(Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic chromosomal disorders and medication use)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0015671
- UMLS CUI [1,3]
- C0262926
- UMLS CUI [1,4]
- C0241889
Beskrivning
Pregnancy Notification Form - Drug Exposures
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C0743284
Beskrivning
Trade Name preferred
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Route of Administration or Formulation
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
- UMLS CUI [2]
- C1705957
Beskrivning
Total Daily Dose
Datatyp
float
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0439810
Beskrivning
Medication Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Medication started pre-study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0332152
- UMLS CUI [2,2]
- C2347804
Beskrivning
Medication start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Medication stop date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
Ongoing medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Reason for medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
Was the subject withdrawn from the study as a result of this pregnancy?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
Reporting Investigator Information
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1533716
Beskrivning
Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Title
Datatyp
text
Alias
- UMLS CUI [1]
- C3888414
Beskrivning
Speciality
Datatyp
text
Alias
- UMLS CUI [1]
- C0037778
Beskrivning
Address
Datatyp
text
Alias
- UMLS CUI [1]
- C1442065
Beskrivning
City or State/Province
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008848
- UMLS CUI [1,2]
- C1547742
Beskrivning
Country
Datatyp
text
Alias
- UMLS CUI [1]
- C0454664
Beskrivning
Post or Zip Code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1514254
- UMLS CUI [1,2]
- C0600091
Beskrivning
Telephone No
Datatyp
integer
Alias
- UMLS CUI [1]
- C1515258
Beskrivning
Fax No
Datatyp
integer
Alias
- UMLS CUI [1]
- C1549619
Beskrivning
(confirming that the data on these pages are accurate and complete)
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator’s signature Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator’s name
Datatyp
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])