ID
25643
Beschreibung
Study part: Pregnancy Notification Form. A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Phase: phase 1. Study Recruitment Status: Completed Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP, Zygara; Zygara, ZIPEREVE, ZEPREVE, Requip Depot, REQUIP, REPREVE, Modutab, ADARTREL. Study Indication : Restless Legs Syndrome. Study ID: 101468/201. Clinical Study ID: 101468/201
Stichworte
Versionen (2)
- 08.09.17 08.09.17 -
- 10.05.19 10.05.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
8. September 2017
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
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.
Pregnancy Notification Form Ropinirole Restless Legs Syndrome 101468/201
Pregnancy Notification Form
- StudyEvent: ODM
Beschreibung
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026591
Beschreibung
(i.e. Include alcohol/tobacco and substance abuse, complications of past pregnancy, labor/delivery, fetus/baby, illness during this pregnancy, assisted conception: specify, other disorders including familial birth defects/genetic/chromosomal disorders, methods of diagnosis consanguinity etc)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0026591
Beschreibung
Number of spontaneous abortion
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Beschreibung
Number of therapeutic abortion
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0032961
Beschreibung
Other
Datentyp
text
Alias
- UMLS CUI [1]
- C0205394
Beschreibung
Full term birth
Datentyp
integer
Alias
- UMLS CUI [1]
- C3814420
Beschreibung
Pre term delivery
Datentyp
integer
Alias
- UMLS CUI [1]
- C4314862
Beschreibung
Stillbirths
Datentyp
integer
Alias
- UMLS CUI [1]
- C0595939
Beschreibung
Deliveries
Datentyp
integer
Alias
- UMLS CUI [1]
- C0011209
Beschreibung
Children born with defects
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Beschreibung
Normal Births
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Beschreibung
Outcome Unknown
Datentyp
integer
Alias
- UMLS CUI [1]
- C0810347
Beschreibung
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
Beschreibung
Information provided by
Datentyp
text
Alias
- UMLS CUI [1]
- C0518629
Beschreibung
Other
Datentyp
text
Alias
- UMLS CUI [1]
- C0205394
Beschreibung
(i.e. Include chronic illnesses: specify, familial birth defects/genetic/chromosomal disorders, habitual exposure: specify, alcohol/tobacco, drug exposure: specify, substance abuse and medication use)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015671
Beschreibung
Father Unknown
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Beschreibung
Number of children
Datentyp
integer
Alias
- UMLS CUI [1]
- C2229974
Beschreibung
Age
Datentyp
integer
Maßeinheiten
- years
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
Race
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Concomitant Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Regimen Dosing
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0178602
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
continuing therapy Concomitant Medication
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2347852
Beschreibung
Indication
Datentyp
text
Alias
- UMLS CUI [1]
- C3146298
Beschreibung
CURRENT PREGNANCY INFORMATION
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschreibung
PREGNANCY STATUS
Alias
- UMLS CUI-1
- C0552579
Beschreibung
Pregnancy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0549206
Beschreibung
Delivery Method
Datentyp
text
Alias
- UMLS CUI [1]
- C0565867
Beschreibung
Stillbirth
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0595939
Beschreibung
Fetal death
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015927
Beschreibung
Early Termination
Datentyp
text
Alias
- UMLS CUI [1]
- C0156543
Beschreibung
FETAL/ NEONATAL STATUS
Alias
- UMLS CUI-1
- C3533197
Beschreibung
INFANT INFORMATION
Alias
- UMLS CUI-1
- C3840300
Beschreibung
Gestational weeks
Datentyp
integer
Maßeinheiten
- Weeks
Alias
- UMLS CUI [1]
- C1954788
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C2348576
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Date of discharge
Datentyp
date
Alias
- UMLS CUI [1]
- C2361123
Beschreibung
Length
Datentyp
float
Alias
- UMLS CUI [1]
- C0221097
Beschreibung
Length
Datentyp
float
Alias
- UMLS CUI [1]
- C0221097
Beschreibung
Weight
Datentyp
float
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Weight
Datentyp
float
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Apgar score
Datentyp
integer
Alias
- UMLS CUI [1]
- C0003533
Beschreibung
multiple births
Datentyp
integer
Alias
- UMLS CUI [1]
- C2015861
Beschreibung
Birth order
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005607
Beschreibung
Discharge summary notes
Datentyp
text
Alias
- UMLS CUI [1]
- C1317307
Beschreibung
Additional details
Datentyp
text
Alias
- UMLS CUI [1]
- C1546922
Beschreibung
RELEVANT LABORATORY TESTS & PROCEDURES
Alias
- UMLS CUI-1
- C0022885
Beschreibung
LABORATORY TESTS
Datentyp
text
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Causations
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085978
Beschreibung
Investigator Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Ähnliche Modelle
Pregnancy Notification Form
- StudyEvent: ODM
C0026591 (UMLS CUI-2)
C0026591 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C2229974 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0015671 (UMLS CUI-2)
C0015671 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
(Comment:en)
(Comment:en)
(Comment:en)