ID

24655

Beschreibung

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.

Stichworte

Versionen (1)
  1. 11.08.17 11.08.17 -
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GlaxoSmithKline

Hochgeladen am

11. August 2017

DOI

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Non- Serious Adverse Event (AE) Ropinirole Restless Legs Syndrom NCT00355641

Englisch

Non- Serious Adverse Event (AE)

1 Formulare  
NON-SERIOUS ADVERSE EVENT (AE)
Beschreibung

NON-SERIOUS ADVERSE EVENT (AE)

Alias
UMLS CUI-1
C1518404
1. Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
2. Event
Beschreibung

Event

Datentyp

text

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

Modified term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beschreibung

MedDRA synonym

Datentyp

text

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

MedDRA lower level term code

Datentyp

text

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

Failed coding

Datentyp

text

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

Adverse Event Start Date Time

Datentyp

datetime

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

Outcome End Date and Time

Datentyp

datetime

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

Frequency

Datentyp

text

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

Maximum Intensity

Datentyp

text

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

Maximum Toxicity

Datentyp

text

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

Maximum Toxicity or Intensity

Datentyp

text

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

Action Taken with Investigational Product

Datentyp

text

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

Withdrawal by Subject

Datentyp

boolean

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

adverse event study drug

Datentyp

boolean

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

duration adverse event

Datentyp

text

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

Time to Onset Since Last Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
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Ähnliche Modelle

Non- Serious Adverse Event (AE)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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