ID
36395
Beschrijving
Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: 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 Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A 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 The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Pregnancy Notification Form. It has to be filled in for each patient who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. After delivery complete the remaining sections and fax the form to GSK. Original pages should remain with the subject’s Case Report Form.
Trefwoorden
Versies (2)
- 08-09-17 08-09-17 -
- 10-05-19 10-05-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
10 mei 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201
Pregnancy Notification Form
- StudyEvent: ODM
Beschrijving
REPORTER INFORMATION
Alias
- UMLS CUI-1
- C3840395
Beschrijving
Reporter name
Datatype
text
Alias
- UMLS CUI [1]
- C1709908
Beschrijving
Title of reporter
Datatype
text
Alias
- UMLS CUI [1]
- C3888414
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1]
- C1442065
Beschrijving
Telephone No
Datatype
integer
Alias
- UMLS CUI [1]
- C1515258
Beschrijving
Fax No
Datatype
integer
Alias
- UMLS CUI [1]
- C1549619
Beschrijving
City
Datatype
text
Alias
- UMLS CUI [1]
- C2316883
Beschrijving
Postal Code
Datatype
integer
Alias
- UMLS CUI [1]
- C1514254
Beschrijving
Country
Datatype
text
Alias
- UMLS CUI [1]
- C1562954
Beschrijving
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026591
Beschrijving
(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)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0026591
Beschrijving
Number of spontaneous abortion
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Beschrijving
Number of therapeutic abortion
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0032961
Beschrijving
Number of previous Pregnancies Terminations- Other
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0205394
Beschrijving
Full term birth
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C3814420
Beschrijving
Pre term delivery
Datatype
integer
Alias
- UMLS CUI [1]
- C4314862
Beschrijving
Stillbirths
Datatype
integer
Alias
- UMLS CUI [1]
- C0595939
Beschrijving
Deliveries
Datatype
integer
Alias
- UMLS CUI [1]
- C0011209
Beschrijving
provide details under mother’s history
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Beschrijving
Normal Births
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Beschrijving
Birth, Outcome Unknown
Datatype
integer
Alias
- UMLS CUI [1]
- C0810347
Beschrijving
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
Beschrijving
Information provided by
Datatype
integer
Alias
- UMLS CUI [1]
- C0518629
Beschrijving
Information provided by Other
Datatype
text
Alias
- UMLS CUI [1]
- C0518629
Beschrijving
(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)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015671
Beschrijving
Father Unknown
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Beschrijving
Number of children
Datatype
integer
Alias
- UMLS CUI [1]
- C2229974
Beschrijving
Age of father
Datatype
integer
Maateenheden
- years
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0001779
Beschrijving
Race of father
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0034510
Beschrijving
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Regimen Dosing
Datatype
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0178602
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Continuing therapy Concomitant Medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2347852
Beschrijving
Indication
Datatype
text
Alias
- UMLS CUI [1]
- C3146298
Beschrijving
CURRENT PREGNANCY INFORMATION
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0425932
Beschrijving
Last menstruation Unknown
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C1287845
Beschrijving
Pregnancy status
Datatype
integer
Alias
- UMLS CUI [1]
- C0552579
Beschrijving
Delivery Method
Datatype
text
Alias
- UMLS CUI [1]
- C0565867
Beschrijving
If you tick other, please note details in "Additional details" section below.
Datatype
integer
Alias
- UMLS CUI [1]
- C0156543
Beschrijving
If you tick Birth defect, please note details in "Additional details" below.
Datatype
integer
Alias
- UMLS CUI [1]
- C3533197
Beschrijving
INFANT INFORMATION
Alias
- UMLS CUI-1
- C3840300
Beschrijving
Gestational weeks
Datatype
integer
Maateenheden
- Weeks
Alias
- UMLS CUI [1]
- C1954788
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2348576
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2361123
Beschrijving
Length of infant, cm
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0221097
Beschrijving
Length of infant, inches
Datatype
float
Maateenheden
- inches
Alias
- UMLS CUI [1]
- C0221097
Beschrijving
Weight of infant, kg
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Weight of infant, lb
Datatype
float
Maateenheden
- lb
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Apgar score
Datatype
integer
Alias
- UMLS CUI [1]
- C0003533
Beschrijving
Multiple births
Datatype
integer
Alias
- UMLS CUI [1]
- C2015861
Beschrijving
(1,2,3,etc) send separate form for each child.
Datatype
integer
Alias
- UMLS CUI [1]
- C0005607
Beschrijving
Discharge summary notes
Datatype
text
Alias
- UMLS CUI [1]
- C1317307
Beschrijving
Additional details
Datatype
text
Alias
- UMLS CUI [1]
- C1546922
Beschrijving
RELEVANT LABORATORY TESTS & PROCEDURES
Alias
- UMLS CUI-1
- C0022885
Beschrijving
(e.g., ultrasound, amniocentesis, chorionic villi sampling, autopsy on products of gestation) In case of an abnormal evolution or outcome, please send a copy of all relevant laboratory tests and procedures and complete the AE or SAE form as appropriate.
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Causations
Datatype
text
Alias
- UMLS CUI [1]
- C0085978
Beschrijving
(if not the same as reporter)
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Reporter’s signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
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])
C0205394 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C3814420 (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])
C0001779 (UMLS CUI [1,2])
C0034510 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C0439673 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])