ID

25460

Beschrijving

Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

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Versies (3)
  1. 23-08-17 23-08-17 -
  2. 23-08-17 23-08-17 -
  3. 04-09-17 04-09-17 -
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4 september 2017

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visit 2,3,4,5 & ongoing adverse events starting dose of ropinirole Parkinson's Disease 101468/166

Engels

visit 2,3,4,5 & ongoing adverse events starting dose of ropinirole Parkinson's Disease 101468/166

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beschrijving

patient's initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beschrijving

patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
1- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Beschrijving

1- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0439568
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
Beschrijving

If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.

Datatype

integer

Alias
UMLS CUI [1]
C0877248
4- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Beschrijving

4- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0439568
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
Beschrijving

If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.

Datatype

integer

Alias
UMLS CUI [1]
C0877248
12- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Beschrijving

12- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0439568
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
Beschrijving

If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.

Datatype

integer

Alias
UMLS CUI [1]
C0877248
24- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Beschrijving

24- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0439568
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
Beschrijving

If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.

Datatype

integer

Alias
UMLS CUI [1]
C0877248
QUERY FOR ADVERSE EVENTS Study Period Visit 3 (Day 4)
Beschrijving

QUERY FOR ADVERSE EVENTS Study Period Visit 3 (Day 4)

Alias
UMLS CUI-1
C0877248
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
Beschrijving

If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.

Datatype

integer

Alias
UMLS CUI [1]
C0877248
QUERY FOR ADVERSE EVENTS Study Period Visit 4 (Day 8)
Beschrijving

QUERY FOR ADVERSE EVENTS Study Period Visit 4 (Day 8)

Alias
UMLS CUI-1
C0877248
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
Beschrijving

If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.

Datatype

integer

Alias
UMLS CUI [1]
C0877248
QUERY FOR ADVERSE EVENTS Study Period Visit 5 (Day 14)
Beschrijving

QUERY FOR ADVERSE EVENTS Study Period Visit 5 (Day 14)

Alias
UMLS CUI-1
C0877248
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
Beschrijving

If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.

Datatype

integer

Alias
UMLS CUI [1]
C0877248
ADVERSE EVENTS Study Period Ongoing
Beschrijving

ADVERSE EVENTS Study Period Ongoing

Alias
UMLS CUI-1
C0877248
Has the patient had any new and/or continuing adverse events?
Beschrijving

If "Yes", indicate below.

Datatype

integer

Alias
UMLS CUI [1]
C0877248
ADVERSE EVENT
Beschrijving

ADVERSE EVENT

Alias
UMLS CUI-1
C0877248
Severity of Adverse Events
Beschrijving

If serious, set a tickmark in the field below. Otherwise leave it empty.

Datatype

text

Alias
UMLS CUI [1]
C1710066
START DATE and TIME
Beschrijving

24-hour clock

Datatype

datetime

Alias
UMLS CUI [1]
C2697888
UMLS CUI [2]
C2697889
STOP DATE and TIME
Beschrijving

if ongoing, please leave blank 24-hour clock

Datatype

datetime

Alias
UMLS CUI [1]
C2697886
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1522314
INTENSITY
Beschrijving

intensity of adverse event

Datatype

integer

Alias
UMLS CUI [1]
C1710066
RELATIONSHIP TO DRUG
Beschrijving

relationship to drug

Datatype

integer

Alias
UMLS CUI [1]
C0277579
ACTION TAKEN WITH TEST DRUG
Beschrijving

change of medication

Datatype

integer

Alias
UMLS CUI [1]
C0580105
CORRECTIVE THERAPY
Beschrijving

If "Yes", record on Concomitant Medication form.

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
EVENT COURSE
Beschrijving

If intermittent, record number of episodes.

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
OUTCOME
Beschrijving

outcome of adverse event

Datatype

integer

Alias
UMLS CUI [1]
C1705586
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Similar models

visit 2,3,4,5 & ongoing adverse events starting dose of ropinirole Parkinson's Disease 101468/166

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
Item Group
1- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
C0877248 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
CL Item
Yes (1)
CL Item
No (2)
Item Group
4- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
C0877248 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
CL Item
Yes (1)
CL Item
No (2)
Item Group
12- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
C0877248 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
CL Item
Yes (1)
CL Item
No (2)
Item Group
24- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
C0877248 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
CL Item
Yes (1)
CL Item
No (2)
Item Group
QUERY FOR ADVERSE EVENTS Study Period Visit 3 (Day 4)
C0877248 (UMLS CUI-1)
Item
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
CL Item
Yes (1)
CL Item
No (2)
Item Group
QUERY FOR ADVERSE EVENTS Study Period Visit 4 (Day 8)
C0877248 (UMLS CUI-1)
Item
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
CL Item
Yes (1)
CL Item
No (2)
Item Group
QUERY FOR ADVERSE EVENTS Study Period Visit 5 (Day 14)
C0877248 (UMLS CUI-1)
Item
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Have there been any adverse events observed or elicited by the following direct question to the patient: "Have you felt different in any way since starting the new treatment?"
CL Item
Yes (1)
CL Item
No (2)
Item Group
ADVERSE EVENTS Study Period Ongoing
C0877248 (UMLS CUI-1)
Item
Has the patient had any new and/or continuing adverse events?
integer
C0877248 (UMLS CUI [1])
adverse events
Code List
Has the patient had any new and/or continuing adverse events?
CL Item
Yes (1)
CL Item
No (2)
Item Group
ADVERSE EVENT
C0877248 (UMLS CUI-1)
Item
Severity of Adverse Events
text
C1710066 (UMLS CUI [1])
severity of adverse events
Code List
Severity of Adverse Events
CL Item
Serious (Serious)
start date and time of adverse event
Item
START DATE and TIME
datetime
C2697888 (UMLS CUI [1])
C2697889 (UMLS CUI [2])
stop date and time of adverse event
Item
STOP DATE and TIME
datetime
C2697886 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
INTENSITY
integer
C1710066 (UMLS CUI [1])
intensity of adverse event
Code List
INTENSITY
CL Item
MILD (1)
CL Item
MODERATE (2)
CL Item
SEVERE (3)
Item
RELATIONSHIP TO DRUG
integer
C0277579 (UMLS CUI [1])
relationship to drug
Code List
RELATIONSHIP TO DRUG
CL Item
NOT RELATED (1)
CL Item
UNLIKELY (2)
CL Item
SUSPECTED (reasonable possibility) (3)
CL Item
PROBABE`LE (4)
Item
ACTION TAKEN WITH TEST DRUG
integer
C0580105 (UMLS CUI [1])
change of medication
Code List
ACTION TAKEN WITH TEST DRUG
CL Item
NONE (1)
CL Item
DOSE REDUCED (2)
CL Item
DOSE INCREASED (3)
CL Item
DRUG INTERRUPTED/RESTARTED (4)
CL Item
DRUG STOPPED (5)
Item
CORRECTIVE THERAPY
integer
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
therapeutic procedure due to adverse event
Code List
CORRECTIVE THERAPY
CL Item
Yes (1)
CL Item
No (2)
Item
EVENT COURSE
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
course of adverse event
Code List
EVENT COURSE
CL Item
INTERMITTENT (1)
CL Item
CONSTANT (2)
Item
OUTCOME
integer
C1705586 (UMLS CUI [1])
outcome of adverse event
Code List
OUTCOME
CL Item
RESOLVED (1)
CL Item
ONGOING (2)
CL Item
DIED (3)
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