ID

24655

Description

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.

Mots-clés

Versions (1)
  1. 11/08/2017 11/08/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

11 août 2017

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Non- Serious Adverse Event (AE)

1 Formulaires  
NON-SERIOUS ADVERSE EVENT (AE)
Description

NON-SERIOUS ADVERSE EVENT (AE)

Alias
UMLS CUI-1
C1518404
1. Sequence Number
Description

Sequence Number

Type de données

integer

Alias
UMLS CUI [1]
C2348184
2. Event
Description

Event

Type de données

text

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

Modified term

Type de données

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Description

MedDRA synonym

Type de données

text

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

MedDRA lower level term code

Type de données

text

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

Failed coding

Type de données

text

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

Adverse Event Start Date Time

Type de données

datetime

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

Outcome End Date and Time

Type de données

datetime

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

Frequency

Type de données

text

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

Maximum Intensity

Type de données

text

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

Maximum Toxicity

Type de données

text

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

Maximum Toxicity or Intensity

Type de données

text

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

Action Taken with Investigational Product

Type de données

text

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

Withdrawal by Subject

Type de données

boolean

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

adverse event study drug

Type de données

boolean

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

duration adverse event

Type de données

text

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

Time to Onset Since Last Dose

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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