ID

29055

Beschrijving

Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Trefwoorden

Versies (5)
  1. 05-10-17 05-10-17 -
  2. 22-02-18 22-02-18 -
  3. 22-02-18 22-02-18 -
  4. 22-02-18 22-02-18 -
  5. 17-09-21 17-09-21 -
Houder van rechten

gsk

Geüploaded op

22 februari 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Ropinirole Case Report Form GSK RRL100013

Engels

Vital signs descirptions

9 Formulieren  
Vital signs
Beschrijving

Vital signs

ADVERSE EVENTS
Beschrijving

Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Event section.

Datatype

text

Alias
UMLS CUI [1]
C0877248
International restless legs syndrome rating scale
Beschrijving

International restless legs syndrome rating scale

Datatype

text

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C0035258
VITAL SIGNS instructions
Beschrijving

Semi-supine measurements must be taken first, followed straight away by the standing measurements. Blood pressure and pulse rate measurements must be recorded in both the semi-supine and standing position. Semi-supine will be defined as the subject lying flat with two pillows under his/her head. Semi-supine pulse and blood measurements will be made after the subject has been resting semi-supine for a period of at least 10 minutes. A standing blood pressure and pulse measurement will be taken after the subject has been standing for a period of one minute. Any clinically significant worsening will be recorded on the Adverse Event or SAE page of the CRF. Blood pressure measurements should not be conducted within 15 minutes of a blood sample. If the blood pressure measurement is conducted after the blood sample, you should ensure that the subject has recovered from the venepuncture before the blood pressure measurement. The blood pressure cuff must be placed on the same arm throughout the study. The same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each clinic visit. Ideally, the same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each patient throughout the study.

Datatype

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1442085
Insomnia severity index
Beschrijving

Insomnia severity index

Datatype

text

Alias
UMLS CUI [1]
C0917801
CENTRAL LABORATORY
Beschrijving

CENTRAL LABORATORY

Datatype

text

Alias
UMLS CUI [1]
C1880016
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure, systolic
Beschrijving

Blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Blood pressure, diastolic
Beschrijving

Blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Body weight
Beschrijving

Body weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Clinical global impression
Beschrijving

Clinical global impression

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C3639708
cm
CONCOMITANT MEDICATIONS
Beschrijving

Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the appropriate Concomitant Medications section.

Datatype

text

Alias
UMLS CUI [1]
C2347852
Terug naar het begin van de pagina

Similar models

Vital signs descirptions

9 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Vital signs
ADVERSE EVENTS
Item
ADVERSE EVENTS
text
C0877248 (UMLS CUI [1])
International restless legs syndrome rating scale
Item
International restless legs syndrome rating scale
text
C0449820 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
VITAL SIGNS instructions
Item
VITAL SIGNS instructions
text
C0518766 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Insomnia severity index
Item
Insomnia severity index
text
C0917801 (UMLS CUI [1])
CENTRAL LABORATORY
Item
CENTRAL LABORATORY
text
C1880016 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood pressure
Item
Blood pressure, systolic
integer
C0005823 (UMLS CUI [1])
Blood pressure
Item
Blood pressure, diastolic
integer
C0005823 (UMLS CUI [1])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Clinical global impression
Item
Clinical global impression
integer
C3639708 (UMLS CUI [1])
CONCOMITANT MEDICATIONS
Item
CONCOMITANT MEDICATIONS
text
C2347852 (UMLS CUI [1])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial