ID
42302
Description
Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases
Keywords
Versions (1)
- 5/18/21 5/18/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 18, 2021
DOI
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License
Creative Commons BY 4.0
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Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812
Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
Description
Pregnancy Notification Form (Subject's Partner) - Mother's Relevant Medical/Family History
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-3
- C1533716
- UMLS CUI-5
- C3887537
- UMLS CUI-7
- C0026591
- UMLS CUI-9
- C0262926
- UMLS CUI-11
- C0241889
Description
Mother's date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0026591
- UMLS CUI [2]
- C0421451
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]
- C0700589
Description
If mother was using method of contraception, please specify.
Data type
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C2348235
Description
Check one
Data type
integer
Alias
- UMLS CUI [1]
- C2598844
Description
(e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Data type
text
Alias
- UMLS CUI [1]
- C0022885
Description
Number of previous pregnancies (Pre-term)
Data type
integer
Alias
- UMLS CUI [1]
- C0422807
- UMLS CUI [2]
- C1547235
Description
Number of previous pregnancies (Full-term)
Data type
integer
Alias
- UMLS CUI [1,1]
- C2114495
- UMLS CUI [1,2]
- C0449788
Description
Number of normal births
Data type
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Description
Number of Stillbirths
Data type
integer
Alias
- UMLS CUI [1,1]
- C0595939
- UMLS CUI [1,2]
- C0449788
Description
Number of Children born with defects
Data type
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Description
Number of Spontaneous abortions
Data type
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Description
Number of Elective abortions
Data type
integer
Alias
- UMLS CUI [1,1]
- C0269439
- UMLS CUI [1,2]
- C0449788
Description
Number of other births
Data type
integer
Alias
- UMLS CUI [1,1]
- C3172256
- UMLS CUI [1,2]
- C0205394
Description
Record details of children born with birth 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]
- C0032972
- UMLS CUI [2]
- C1521761
Description
Specify factor that may have an impact on the outcome of this pregnancy
Data type
text
Alias
- UMLS CUI [1]
- C0032972
- UMLS CUI [2]
- C1521761
- UMLS CUI [3]
- C2348235
Description
Pregnancy Notification Form (Subject's Partner) - Father's Relevant Medical/Family History
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C3887537
- UMLS CUI-4
- C0015671
- UMLS CUI-5
- C0262926
- UMLS CUI-6
- C0241889
Description
Pregnancy Notification Form (Subject's Partner) - Drug Exposures
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C3887537
- UMLS CUI-4
- C0743284
Description
Drug Name
Data type
text
Alias
- UMLS CUI [1]
- C2360065
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]
- C2348070
Description
Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Medication Started Pre-Study
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2,1]
- C0808070
- UMLS CUI [2,2]
- C0332152
- UMLS CUI [3]
- 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?
Alias
- UMLS CUI-1
- C0422727
- UMLS CUI-3
- C0032961
Description
Pregnancy Notification Form (Subject's Partner) - Reporting Investigator Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C3887537
- UMLS CUI-5
- C0008961
- UMLS CUI-6
- 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
Adress
Data type
text
Alias
- UMLS CUI [1]
- C1301826
Description
City or State/Province
Data type
text
Alias
- UMLS CUI [1]
- C0008848
- UMLS CUI [2]
- C1547742
Description
Country
Data type
text
Alias
- UMLS CUI [1]
- C0454664
Description
Post or Zip Code
Data type
text
Alias
- UMLS CUI [1]
- C0421454
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
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- StudyEvent: ODM
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C0026591 (UMLS CUI-7)
C0262926 (UMLS CUI-9)
C0241889 (UMLS CUI-11)
C0421451 (UMLS CUI [2])
C2348235 (UMLS CUI [1,2])
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C0449788 (UMLS CUI [1,2])
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C0449788 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,2])
C1521761 (UMLS CUI [2])
C1521761 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C1533716 (UMLS CUI-2)
C3887537 (UMLS CUI-3)
C0015671 (UMLS CUI-4)
C0262926 (UMLS CUI-5)
C0241889 (UMLS CUI-6)
C0262926 (UMLS CUI [2])
C0241889 (UMLS CUI [3])
C1533716 (UMLS CUI-2)
C3887537 (UMLS CUI-3)
C0743284 (UMLS CUI-4)
C1705957 (UMLS CUI [2])
C0808070 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C2347804 (UMLS CUI [3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0032961 (UMLS CUI-3)
C0032961 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C3887537 (UMLS CUI-3)
C0008961 (UMLS CUI-5)
C1533716 (UMLS CUI-6)
C1547742 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])