ID
42302
Beskrivning
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
Nyckelord
Versioner (1)
- 2021-05-18 2021-05-18 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
18 maj 2021
DOI
För en begäran logga in.
Licens
Creative Commons BY 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812
Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
Beskrivning
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
Beskrivning
Mother's date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0026591
- UMLS CUI [2]
- C0421451
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]
- C0700589
Beskrivning
If mother was using method of contraception, please specify.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C2348235
Beskrivning
Check one
Datatyp
integer
Alias
- UMLS CUI [1]
- C2598844
Beskrivning
(e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Number of previous pregnancies (Pre-term)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0422807
- UMLS CUI [2]
- C1547235
Beskrivning
Number of previous pregnancies (Full-term)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2114495
- UMLS CUI [1,2]
- C0449788
Beskrivning
Number of normal births
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Beskrivning
Number of Stillbirths
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0595939
- UMLS CUI [1,2]
- C0449788
Beskrivning
Number of Children born with defects
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Beskrivning
Number of Spontaneous abortions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Beskrivning
Number of Elective abortions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0269439
- UMLS CUI [1,2]
- C0449788
Beskrivning
Number of other births
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3172256
- UMLS CUI [1,2]
- C0205394
Beskrivning
Record details of children born with birth 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]
- C0032972
- UMLS CUI [2]
- C1521761
Beskrivning
Specify factor that may have an impact on the outcome of this pregnancy
Datatyp
text
Alias
- UMLS CUI [1]
- C0032972
- UMLS CUI [2]
- C1521761
- UMLS CUI [3]
- C2348235
Beskrivning
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
Beskrivning
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
Beskrivning
Drug Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2360065
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]
- C2348070
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Medication Started Pre-Study
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2,1]
- C0808070
- UMLS CUI [2,2]
- C0332152
- UMLS CUI [3]
- 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?
Alias
- UMLS CUI-1
- C0422727
- UMLS CUI-3
- C0032961
Beskrivning
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
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
Adress
Datatyp
text
Alias
- UMLS CUI [1]
- C1301826
Beskrivning
City or State/Province
Datatyp
text
Alias
- UMLS CUI [1]
- C0008848
- UMLS CUI [2]
- C1547742
Beskrivning
Country
Datatyp
text
Alias
- UMLS CUI [1]
- C0454664
Beskrivning
Post or Zip Code
Datatyp
text
Alias
- UMLS CUI [1]
- C0421454
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])
C1533716 (UMLS CUI-3)
C3887537 (UMLS CUI-5)
C0026591 (UMLS CUI-7)
C0262926 (UMLS CUI-9)
C0241889 (UMLS CUI-11)
C0421451 (UMLS CUI [2])
C2348235 (UMLS CUI [1,2])
C1547235 (UMLS CUI [2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C2229974 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
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])