ID

24655

Beschrijving

Study part: Non- Serious Adverse Event (AE). 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.

Trefwoorden

Versies (1)
  1. 11-08-17 11-08-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 augustus 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Non- Serious Adverse Event (AE) Ropinirole Restless Legs Syndrom NCT00355641

Engels

Non- Serious Adverse Event (AE)

1 Formulieren  
NON-SERIOUS ADVERSE EVENT (AE)
Beschrijving

NON-SERIOUS ADVERSE EVENT (AE)

Alias
UMLS CUI-1
C1518404
1. Sequence Number
Beschrijving

Sequence Number

Datatype

integer

Alias
UMLS CUI [1]
C2348184
2. Event
Beschrijving

Event

Datatype

text

Alias
UMLS CUI [1]
C0877248
3. Modified term
Beschrijving

Modified term

Datatype

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beschrijving

MedDRA synonym

Datatype

text

Alias
UMLS CUI [1,1]
C0871468
UMLS CUI [1,2]
C1518404
MedDRA lower level term code
Beschrijving

MedDRA lower level term code

Datatype

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1518404
Failed coding
Beschrijving

Failed coding

Datatype

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
4. Start Date and Time
Beschrijving

Adverse Event Start Date Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826806
5. Outcome / End Date and Time
Beschrijving

Outcome End Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C2826793
6. Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C1561548
7.Maximum Intensity
Beschrijving

Maximum Intensity

Datatype

text

Alias
UMLS CUI [1]
C1710056
8. Maximum Toxicity
Beschrijving

Maximum Toxicity

Datatype

text

Alias
UMLS CUI [1]
C1710066
9. Maximum Toxicity or Intensity
Beschrijving

Maximum Toxicity or Intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
10. Action Taken with Investigational Product(s) as a Result of the AE
Beschrijving

Action Taken with Investigational Product

Datatype

text

Alias
UMLS CUI [1]
C1704758
11. Did the subject withdraw from study as a result of this AE?
Beschrijving

Withdrawal by Subject

Datatype

boolean

Alias
UMLS CUI [1]
C1710677
12. Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

adverse event study drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0008972
13. Duration of AE if < 24 hours
Beschrijving

duration adverse event

Datatype

text

Alias
UMLS CUI [1,1]
C0449238
14. Time to Onset Since Last Dose
Beschrijving

Time to Onset Since Last Dose

Datatype

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
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Similar models

Non- Serious Adverse Event (AE)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
NON-SERIOUS ADVERSE EVENT (AE)
C1518404 (UMLS CUI-1)
Sequence Number
Item
1. Sequence Number
integer
C2348184 (UMLS CUI [1])
Event
Item
2. Event
text
C0877248 (UMLS CUI [1])
Modified term
Item
3. Modified term
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C0871468 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Adverse Event Start Date Time
Item
4. Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Outcome End Date and Time
Item
5. Outcome / End Date and Time
datetime
C1705586 (UMLS CUI [1,1])
C2826793 (UMLS CUI [1,2])
Item
6. Frequency
text
C1561548 (UMLS CUI [1])
Frequency
Code List
6. Frequency
CL Item
Single Episode (Single Episode)
CL Item
Intermittent (Intermittent)
Item
7.Maximum Intensity
text
C1710056 (UMLS CUI [1])
Maximum Intensity
Code List
7.Maximum Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Not applicable (Not applicable)
Item
8. Maximum Toxicity
text
C1710066 (UMLS CUI [1])
Maximum Toxicity
Code List
8. Maximum Toxicity
CL Item
Grade 1 (Grade 1)
CL Item
Grade 2 (Grade 2)
CL Item
Grade 3 (Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 (Grade 5)
CL Item
Not applicable (Not applicable)
Item
9. Maximum Toxicity or Intensity
text
C1710066 (UMLS CUI [1])
Maximum Toxicity or Intensity
Code List
9. Maximum Toxicity or Intensity
CL Item
Mild or Grade 1 (Mild or Grade 1)
CL Item
Moderate or Grade 2 (Moderate or Grade 2)
CL Item
Severe or Grade 3 (Severe or Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Grade 5 (Grade 5)
CL Item
Not applicable (Not applicable)
Item
10. Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
10. Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
Withdrawal by Subject
Item
11. Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1])
adverse event study drug
Item
12. Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
duration adverse event
Item
13. Duration of AE if < 24 hours
text
C0449238 (UMLS CUI [1,1])
Time to Onset Since Last Dose
Item
14. Time to Onset Since Last Dose
time
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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