ID

24552

Description

Study part: Study Conclusion. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. Phase: phase 3. 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: 101468/206. Clinical Study ID: 101468/206.

Mots-clés

Versions (1)
  1. 05/08/2017 05/08/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

5 août 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Study Conclusion (CONC) Ropinirole Restless Legs Syndrom NCT00355641

Anglais

Study Conclusion

1 Formulaires  
  1. StudyEvent: ODM
    1. Study Conclusion
STUDY CONCLUSION
Description

STUDY CONCLUSION

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
1. Date of subject completion or date of subject withdrawal
Description

date subject withdrawal

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0422727
2. Was the subject withdrawn from the study?
Description

subject withdrawal

Type de données

boolean

Alias
UMLS CUI [1]
C0422727
If Yes, select primary reason for withdrawal
Description

reason

Type de données

text

Alias
UMLS CUI [1]
C0392360
Other, specify
Description

Other

Type de données

text

Alias
UMLS CUI [1]
C0205394
LOG STATUS
Description

LOG STATUS

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
3. Did the subject experience any non-serious adverse events during the study?
Description

non-serious adverse events

Type de données

boolean

Alias
UMLS CUI [1]
C1518404
4. Did the subject experience any serious adverse events during the study?
Description

serious adverse events

Type de données

boolean

Alias
UMLS CUI [1]
C1519255
5. Were any concomitant medications taken by the subject prior to screening and/or during the study?
Description

concomitant medications

Type de données

boolean

Alias
UMLS CUI [1]
C2347852
6. Case book ready for signature
Description

signature

Type de données

boolean

Alias
UMLS CUI [1]
C1519316
7. Q1
Description

Q1

Type de données

boolean

8. Q2
Description

Q2

Type de données

text

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Similar models

Study Conclusion

1 Formulaires
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
STUDY CONCLUSION
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
date subject withdrawal
Item
1. Date of subject completion or date of subject withdrawal
date
C0011008 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
subject withdrawal
Item
2. Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If Yes, select primary reason for withdrawal
text
C0392360 (UMLS CUI [1])
reason
Code List
If Yes, select primary reason for withdrawal
CL Item
Adverse Event (Adverse Event)
C0877248 (UMLS CUI-1)
(Comment:en)
CL Item
Lost to follow-up (Lost to follow-up)
C1302313 (UMLS CUI-1)
(Comment:en)
CL Item
Protocol violation (Protocol violation)
C1709750 (UMLS CUI-1)
(Comment:en)
CL Item
Subject decided to withdraw from the study (Subject decided to withdraw from the study)
C2348571 (UMLS CUI-1)
(Comment:en)
CL Item
Insufficient therapeutic effect (Insufficient therapeutic effect)
C1546939 (UMLS CUI-1)
(Comment:en)
CL Item
Other (Other)
C0205394 (UMLS CUI-1)
(Comment:en)
Other
Item
Other, specify
text
C0205394 (UMLS CUI [1])
Item Group
LOG STATUS
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
non-serious adverse events
Item
3. Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
serious adverse events
Item
4. Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
concomitant medications
Item
5. Were any concomitant medications taken by the subject prior to screening and/or during the study?
boolean
C2347852 (UMLS CUI [1])
signature
Item
6. Case book ready for signature
boolean
C1519316 (UMLS CUI [1])
Q1
Item
7. Q1
boolean
Item
8. Q2
text
Q2
Code List
8. Q2
CL Item
PF_SC_LOST (PF_SC_LOST)
CL Item
PF_SC_DEATH (PF_SC_DEATH)
CL Item
PF_SC_SPONSORDECISION (PF_SC_SPONSORDECISION)
CL Item
PF_SC_PHYSICIANDECISION (PF_SC_PHYSICIANDECISION)
CL Item
PF_SC_PATIENTDECISION (PF_SC_PATIENTDECISION)
CL Item
PF_SC_AE (PF_SC_AE)
CL Item
PF_SC_ALE (PF_SC_ALE)
CL Item
PF_SC_CRITERIA (PF_SC_CRITERIA)
CL Item
PF_SC_OTHER (PF_SC_OTHER)
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