ID
36395
Description
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.
Mots-clés
Versions (2)
- 08/09/2017 08/09/2017 -
- 10/05/2019 10/05/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
10 mai 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201
Pregnancy Notification Form
- StudyEvent: ODM
Description
REPORTER INFORMATION
Alias
- UMLS CUI-1
- C3840395
Description
Reporter name
Type de données
text
Alias
- UMLS CUI [1]
- C1709908
Description
Title of reporter
Type de données
text
Alias
- UMLS CUI [1]
- C3888414
Description
Address
Type de données
text
Alias
- UMLS CUI [1]
- C1442065
Description
Telephone No
Type de données
integer
Alias
- UMLS CUI [1]
- C1515258
Description
Fax No
Type de données
integer
Alias
- UMLS CUI [1]
- C1549619
Description
City
Type de données
text
Alias
- UMLS CUI [1]
- C2316883
Description
Postal Code
Type de données
integer
Alias
- UMLS CUI [1]
- C1514254
Description
Country
Type de données
text
Alias
- UMLS CUI [1]
- C1562954
Description
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026591
Description
(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)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0026591
Description
Number of spontaneous abortion
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0000786
- UMLS CUI [1,2]
- C0449788
Description
Number of therapeutic abortion
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0032961
Description
Number of previous Pregnancies Terminations- Other
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0422807
- UMLS CUI [1,2]
- C0205394
Description
Full term birth
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0030705
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C3814420
Description
Pre term delivery
Type de données
integer
Alias
- UMLS CUI [1]
- C4314862
Description
Stillbirths
Type de données
integer
Alias
- UMLS CUI [1]
- C0595939
Description
Deliveries
Type de données
integer
Alias
- UMLS CUI [1]
- C0011209
Description
provide details under mother’s history
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C2229974
Description
Normal Births
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3665337
- UMLS CUI [1,2]
- C0449788
Description
Birth, Outcome Unknown
Type de données
integer
Alias
- UMLS CUI [1]
- C0810347
Description
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0015671
Description
Information provided by
Type de données
integer
Alias
- UMLS CUI [1]
- C0518629
Description
Information provided by Other
Type de données
text
Alias
- UMLS CUI [1]
- C0518629
Description
(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)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015671
Description
Father Unknown
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Description
Number of children
Type de données
integer
Alias
- UMLS CUI [1]
- C2229974
Description
Age of father
Type de données
integer
Unités de mesure
- years
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0001779
Description
Race of father
Type de données
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0034510
Description
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
Alias
- UMLS CUI-1
- C2347852
Description
Concomitant Medication
Type de données
text
Alias
- UMLS CUI [1]
- C2347852
Description
Regimen Dosing
Type de données
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C0178602
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0808070
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0806020
Description
Continuing therapy Concomitant Medication
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2347852
Description
Indication
Type de données
text
Alias
- UMLS CUI [1]
- C3146298
Description
CURRENT PREGNANCY INFORMATION
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0425932
Description
Last menstruation Unknown
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C1287845
Description
Pregnancy status
Type de données
integer
Alias
- UMLS CUI [1]
- C0552579
Description
Delivery Method
Type de données
text
Alias
- UMLS CUI [1]
- C0565867
Description
If you tick other, please note details in "Additional details" section below.
Type de données
integer
Alias
- UMLS CUI [1]
- C0156543
Description
If you tick Birth defect, please note details in "Additional details" below.
Type de données
integer
Alias
- UMLS CUI [1]
- C3533197
Description
INFANT INFORMATION
Alias
- UMLS CUI-1
- C3840300
Description
Gestational weeks
Type de données
integer
Unités de mesure
- Weeks
Alias
- UMLS CUI [1]
- C1954788
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C2348576
Description
Sex
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C2361123
Description
Length of infant, cm
Type de données
float
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0221097
Description
Length of infant, inches
Type de données
float
Unités de mesure
- inches
Alias
- UMLS CUI [1]
- C0221097
Description
Weight of infant, kg
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Weight of infant, lb
Type de données
float
Unités de mesure
- lb
Alias
- UMLS CUI [1]
- C0005910
Description
Apgar score
Type de données
integer
Alias
- UMLS CUI [1]
- C0003533
Description
Multiple births
Type de données
integer
Alias
- UMLS CUI [1]
- C2015861
Description
(1,2,3,etc) send separate form for each child.
Type de données
integer
Alias
- UMLS CUI [1]
- C0005607
Description
Discharge summary notes
Type de données
text
Alias
- UMLS CUI [1]
- C1317307
Description
Additional details
Type de données
text
Alias
- UMLS CUI [1]
- C1546922
Description
RELEVANT LABORATORY TESTS & PROCEDURES
Alias
- UMLS CUI-1
- C0022885
Description
(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.
Type de données
text
Alias
- UMLS CUI [1]
- C0022885
Description
Causations
Type de données
text
Alias
- UMLS CUI [1]
- C0085978
Description
(if not the same as reporter)
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Reporter’s signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
day month year
Type de données
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])