Information:
Fel:
ID
20711
Beskrivning
Documentation Part: Serious Adverse Events (SAE) An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline
Länk
https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1
Nyckelord
Versioner (1)
- 2017-03-13 2017-03-13 -
Uppladdad den
13 mars 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Serious Adverse Events (SAE) Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Serious Adverse Events (SAE) Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Similar models
Serious Adverse Events (SAE) Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
Code List
Did the subject experience a serious adverse event during the study?
CL Item
Yes (Y)
CL Item
No (N)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Actions taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1])
Code List
Actions taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Doce increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this SAE?
text
C0422727 (UMLS CUI [1])
Code List
Did the subject withdraw from study as a result of this SAE?
CL Item
No (N)
CL Item
Yes (Y)
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Is there a reasonable possibility the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item
If fatal, was a post-mortem/autopsy performed
text
C0004398 (UMLS CUI [1])
Code List
If fatal, was a post-mortem/autopsy performed
CL Item
Yes (Y)
CL Item
No (N)
Item
Specify reason(s) for considering this a SAE, tick all that apply:
text
C1710056 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a SAE, tick all that apply:
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other (F)
If Other, specify:
Item
If Other, specify:
text
C2348235 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C2826663 (UMLS CUI [1])
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
Possible Causes of SAE Other Than Investigational Product(s)
text
C0015127 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Possible Causes of SAE Other Than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other (7)
If
Item
If "Medical condition(s)", specify:
text
C2348235 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
If "Concomitant medication(s)", specify:
Item
If "Concomitant medication(s)", specify:
text
C2348235 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
If "Other", specify:
Item
If "Other", specify:
text
C2348235 (UMLS CUI [1])
Item Group
Section 6 Relevant Medical Conditions
C0012634 (UMLS CUI-1)
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Item
Condition Present at Time of the SAE?
text
C3827351 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
If No, Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
If No, Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Section 7 Other RELEVANT Risk Factors
C0035648 (UMLS CUI-1)
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Item
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
text
C0035648 (UMLS CUI [1])
Item Group
Section 8 RELEVANT Concomitant Medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C2348328 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Taken Prior to Study
Item
Taken Prior to Study
boolean
C2826667 (UMLS CUI [1])
Start Date
Item
Start Date
date
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Item Group
Section 9 Details of Investigation Product(s)
C0013230 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
C1522508 (UMLS CUI-2)
Date of Dose
Item
Date of Dose
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of Dose
Item
Time of Dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item Group
Section 10 Details of RELEVANT Assessments
C1261322 (UMLS CUI-1)
Details of RELEVANT Assessments
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
text
C1261322 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C3897642 (UMLS CUI [1])
Investigator's signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])