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Informações:
Falhas:
ID
25643
Descrição
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
Palavras-chave
Versões (2)
- 08/09/2017 08/09/2017 -
- 10/05/2019 10/05/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
8 de setembro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Pregnancy Notification Form Ropinirole Restless Legs Syndrome 101468/201
Pregnancy Notification Form
- StudyEvent: ODM
Similar models
Pregnancy Notification Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Reporter
Item
Reporter name:
text
C1709908 (UMLS CUI [1])
Title
Item
Title:
text
C3888414 (UMLS CUI [1])
Address
Item
Address:
text
C1442065 (UMLS CUI [1])
Telephone No
Item
Telephone No:
integer
C1515258 (UMLS CUI [1])
Fax No
Item
Fax No:
integer
C1549619 (UMLS CUI [1])
City
Item
City, State/Province:
text
C2316883 (UMLS CUI [1])
Postal Code
Item
Postal Code:
integer
C1514254 (UMLS CUI [1])
Country
Item
Country
text
C1562954 (UMLS CUI [1])
Item Group
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
C0262926 (UMLS CUI-1)
C0026591 (UMLS CUI-2)
C0026591 (UMLS CUI-2)
medical history mother
Item
Family or Medical History
text
C0262926 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0026591 (UMLS CUI [1,2])
Number of spontaneous abortion
Item
Number of spontaneous abortion:
integer
C0000786 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Number of therapeutic abortion
Item
Number of therapeutic abortion:
integer
C0030705 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Other
Item
Number of previous Pregnancies Terminations- Other:
text
C0205394 (UMLS CUI [1])
Full term birth
Item
Full term:
integer
C3814420 (UMLS CUI [1])
Pre term delivery
Item
Pre term:
integer
C4314862 (UMLS CUI [1])
Stillbirths
Item
Stillbirths:
integer
C0595939 (UMLS CUI [1])
Deliveries
Item
Deliveries:
integer
C0011209 (UMLS CUI [1])
Children born with defects
Item
Children born with defects:
integer
C0000768 (UMLS CUI [1,1])
C2229974 (UMLS CUI [1,2])
C2229974 (UMLS CUI [1,2])
Normal Births
Item
Normal Births:
integer
C3665337 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Outcome Unknown
Item
Outcome Unknown:
integer
C0810347 (UMLS CUI [1])
Item Group
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
C0262926 (UMLS CUI-1)
C0015671 (UMLS CUI-2)
C0015671 (UMLS CUI-2)
CL Item
Father (Father)
CL Item
Other (Other)
Other
Item
Other, please specify:
text
C0205394 (UMLS CUI [1])
medical history father
Item
Medical Or Family History
text
C0262926 (UMLS CUI [1,1])
C0015671 (UMLS CUI [1,2])
C0015671 (UMLS CUI [1,2])
Father Unknown
Item
Father Unknown
boolean
C0015671 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
Number of children
Item
Number of children:
integer
C2229974 (UMLS CUI [1])
Age
Item
Age:
integer
C0001779 (UMLS CUI [1])
Race
Item
Race:
text
C0034510 (UMLS CUI [1])
Item Group
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Reported Drug/ Vaccine/OTC name (generic or trade name)
text
C2347852 (UMLS CUI [1])
Regimen Dosing
Item
Dosing Regimen & Frequency of Dosing
text
C1276413 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
continuing therapy Concomitant Medication
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Item Group
CURRENT PREGNANCY INFORMATION
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1533716 (UMLS CUI-2)
Date of last menstrual period
Item
Date of last menstrual period
date
C0425932 (UMLS CUI [1])
Unknown
Item
Unknown
boolean
C0439673 (UMLS CUI [1])
Estimated date of delivery
Item
Estimated date of delivery
date
C1287845 (UMLS CUI [1])
Pregnancy
Item
Pregnancy Ongoing
boolean
C0549206 (UMLS CUI [1])
Delivery Method
Item
Delivery Method:
text
C0565867 (UMLS CUI [1])
Stillbirth
Item
Stillbirth
boolean
C0595939 (UMLS CUI [1])
Fetal death
Item
Fetal death
boolean
C0015927 (UMLS CUI [1])
CL Item
Spontaneous abortion (Spontaneous abortion)
C0000786 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Therapeutic abortion (Therapeutic abortion)
C3146284 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Other (Other)
C0205394 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Normal (1)
CL Item
Birth defect (structural/chromosomal disorder) (2)
CL Item
Other disorder (non-structural, premature birth,intrauterine death/stillbirth) (3)
Gestational weeks
Item
Gestational weeks at birth/miscarriage/ termination:
integer
C1954788 (UMLS CUI [1])
Date of birth
Item
Date of birth/miscarriage/termination:
date
C2348576 (UMLS CUI [1])
CL Item
Male (Male)
CL Item
Female (Female)
CL Item
Unknown (Unknown)
Date of discharge
Item
Date of discharge:
date
C2361123 (UMLS CUI [1])
Length
Item
Length in cm
float
C0221097 (UMLS CUI [1])
Length
Item
Length in inches
float
C0221097 (UMLS CUI [1])
Weight
Item
Weight in kg
float
C0005910 (UMLS CUI [1])
Weight
Item
Weight in lb
float
C0005910 (UMLS CUI [1])
Apgar score
Item
Apgar score (0-10):
integer
C0003533 (UMLS CUI [1])
multiple births
Item
If multiple births (e.g., twins), indicate number:
integer
C2015861 (UMLS CUI [1])
Birth order
Item
Birth order (1,2,3,etc)
integer
C0005607 (UMLS CUI [1])
Discharge summary notes
Item
Discharge summary notes:
text
C1317307 (UMLS CUI [1])
Additional details
Item
Additional details on current pregnancy, labor/delivery, fetus and/or infant:
text
C1546922 (UMLS CUI [1])
LABORATORY TESTS
Item
RELEVANT LABORATORY TESTS & PROCEDURES (e.g., ultrasound, amniocentesis, chorionic villi sampling, autopsy on products of gestation)
text
C0022885 (UMLS CUI [1])
Causations
Item
If any problems occurred, do you believe they may be drug ( or vaccine) related?
boolean
C0085978 (UMLS CUI [1])
Investigator Name
Item
Investigator Name:
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])