ID
42302
Beschreibung
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
Stichworte
Versionen (1)
- 18.05.21 18.05.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
18. Mai 2021
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812
Pregnancy Notification Form (Subject's Partner)
- StudyEvent: ODM
Beschreibung
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
Beschreibung
Mother's date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0026591
- UMLS CUI [2]
- C0421451
Beschreibung
Date of last menstrual period
Datentyp
date
Alias
- UMLS CUI [1]
- C0425932
Beschreibung
Estimated date of delivery
Datentyp
date
Alias
- UMLS CUI [1]
- C1287845
Beschreibung
Was the mother using a method of contraception?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
If mother was using method of contraception, please specify.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C2348235
Beschreibung
Check one
Datentyp
integer
Alias
- UMLS CUI [1]
- C2598844
Beschreibung
(e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Datentyp
text
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Number of previous pregnancies (Pre-term)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0422807
- UMLS CUI [2]
- C1547235
Beschreibung
Number of previous pregnancies (Full-term)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2114495
- UMLS CUI [1,2]
- C0449788
Beschreibung
Number of normal births
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Beschreibung
Number of Stillbirths
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0595939
- UMLS CUI [1,2]
- C0449788
Beschreibung
Number of Children born with defects
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Beschreibung
Number of Spontaneous abortions
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Beschreibung
Number of Elective abortions
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0269439
- UMLS CUI [1,2]
- C0449788
Beschreibung
Number of other births
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3172256
- UMLS CUI [1,2]
- C0205394
Beschreibung
Record details of children born with birth defects
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0000768
Beschreibung
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032972
- UMLS CUI [2]
- C1521761
Beschreibung
Specify factor that may have an impact on the outcome of this pregnancy
Datentyp
text
Alias
- UMLS CUI [1]
- C0032972
- UMLS CUI [2]
- C1521761
- UMLS CUI [3]
- C2348235
Beschreibung
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
Beschreibung
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
Beschreibung
Drug Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
Beschreibung
Route of Administration or Formulation
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
- UMLS CUI [2]
- C1705957
Beschreibung
Total Daily Dose
Datentyp
float
Alias
- UMLS CUI [1]
- C2348070
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Medication Started Pre-Study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2,1]
- C0808070
- UMLS CUI [2,2]
- C0332152
- UMLS CUI [3]
- C2347804
Beschreibung
Medication Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
Medication Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschreibung
Ongoing Medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
Was the subject withdrawn from the study as a result of this pregnancy?
Alias
- UMLS CUI-1
- C0422727
- UMLS CUI-3
- C0032961
Beschreibung
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
Beschreibung
Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Title
Datentyp
text
Alias
- UMLS CUI [1]
- C3888414
Beschreibung
Speciality
Datentyp
text
Alias
- UMLS CUI [1]
- C0037778
Beschreibung
Adress
Datentyp
text
Alias
- UMLS CUI [1]
- C1301826
Beschreibung
City or State/Province
Datentyp
text
Alias
- UMLS CUI [1]
- C0008848
- UMLS CUI [2]
- C1547742
Beschreibung
Country
Datentyp
text
Alias
- UMLS CUI [1]
- C0454664
Beschreibung
Post or Zip Code
Datentyp
text
Alias
- UMLS CUI [1]
- C0421454
Beschreibung
Telephone No
Datentyp
integer
Alias
- UMLS CUI [1]
- C1515258
Beschreibung
Fax No
Datentyp
integer
Alias
- UMLS CUI [1]
- C1549619
Beschreibung
(confirming that the data on these pages are accurate and complete)
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator's Signature Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Investigator's name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Ähnliche Modelle
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])