ID

20711

Beschreibung

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

Link

https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1

Stichworte

Versionen (1)
  1. 13.03.17 13.03.17 -
Hochgeladen am

13. März 2017

DOI

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Lizenz

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

Englisch

Serious Adverse Events (SAE) Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 Formulare  
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Beschreibung

Randomisation Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Section 1
Beschreibung

Section 1

Alias
UMLS CUI-1
C1828479
Did the subject experience a serious adverse event during the study?
Beschreibung

If Yes, record details below.

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschreibung

Start Date

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Day Month Year
Start Time
Beschreibung

Start Time

Datentyp

time

Maßeinheiten
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1519255
Hr : Min
Outcome
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
End Date
Beschreibung

If fatal, record date of death.

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Day Month Year
End Time
Beschreibung

End Time

Datentyp

time

Maßeinheiten
  • Hr : Min
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Hr : Min
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Actions taken with Investigational Product(s) as a Result of the SAE
Beschreibung

Actions taken with Investigational Product(s) as a Result of the SAE

Datentyp

text

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

Did the subject withdraw from study as a result of this SAE?

Datentyp

text

Alias
UMLS CUI [1]
C0422727
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Beschreibung

Is there a reasonable possibility the SAE may have been caused by the investigational product?

Datentyp

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
If fatal, was a post-mortem/autopsy performed
Beschreibung

If Yes, summarize findings in Section 11 Narrative Remarks of this SAE form.

Datentyp

text

Alias
UMLS CUI [1]
C0004398
Section 2 Seriousness
Beschreibung

Section 2 Seriousness

Alias
UMLS CUI-1
C1710056
Specify reason(s) for considering this a SAE, tick all that apply:
Beschreibung

Specify reason(s) for considering this a SAE, tick all that apply:

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C2348235
If Other, specify:
Beschreibung

If Other, specify:

Datentyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C1710056
Section 3 Demography Data
Beschreibung

Section 3 Demography Data

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1]
C0421451
Day Month Year
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Section 4
Beschreibung

Section 4

Alias
UMLS CUI-1
C0877248
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschreibung

If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?

Datentyp

text

Alias
UMLS CUI [1]
C2826663
Section 5
Beschreibung

Section 5

Alias
UMLS CUI-1
C0015127
UMLS CUI-2
C1519255
Possible Causes of SAE Other Than Investigational Product(s)
Beschreibung

Possible Causes of SAE Other Than Investigational Product(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1519255
If "Medical condition(s)", specify:
Beschreibung

If

Datentyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0012634
If "Concomitant medication(s)", specify:
Beschreibung

If "Concomitant medication(s)", specify:

Datentyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C2347852
If "Other", specify:
Beschreibung

If "Other", specify:

Datentyp

text

Alias
UMLS CUI [1]
C2348235
Section 6 Relevant Medical Conditions
Beschreibung

Section 6 Relevant Medical Conditions

Alias
UMLS CUI-1
C0012634
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Beschreibung

Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
Date of Onset
Beschreibung

Date of Onset

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1]
C0574845
Day Month Year
Condition Present at Time of the SAE?
Beschreibung

Condition Present at Time of the SAE?

Datentyp

text

Alias
UMLS CUI [1,1]
C3827351
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence
Beschreibung

If No, Date of Last Occurrence

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0011008
Day Month Year
If No, Date of Last Occurrence
Beschreibung

If No, Date of Last Occurrence

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0011008
Day Month Year
Section 7 Other RELEVANT Risk Factors
Beschreibung

Section 7 Other RELEVANT Risk Factors

Alias
UMLS CUI-1
C0035648
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Beschreibung

Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)

Datentyp

text

Alias
UMLS CUI [1]
C0035648
Section 8 RELEVANT Concomitant Medications
Beschreibung

Section 8 RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beschreibung

Dose

Datentyp

float

Alias
UMLS CUI [1]
C3174092
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1]
C2348328
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study
Beschreibung

Taken Prior to Study

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beschreibung

Start Date

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
Day Month Year
Stop Date
Beschreibung

Stop Date

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0806020
Day Month Year
Ongoing Medication?
Beschreibung

Ongoing Medication?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Section 9 Details of Investigation Product(s)
Beschreibung

Section 9 Details of Investigation Product(s)

Alias
UMLS CUI-1
C0013230
UMLS CUI-2
C1522508
Date of Dose
Beschreibung

Date of Dose

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011008
Day Month Year
Time of Dose
Beschreibung

Time of Dose

Datentyp

time

Maßeinheiten
  • Hr : Min
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Hr : Min
Section 10 Details of RELEVANT Assessments
Beschreibung

Section 10 Details of RELEVANT Assessments

Alias
UMLS CUI-1
C1261322
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)
Beschreibung

Details of RELEVANT Assessments

Datentyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1522508
Section 11 Narrative Remarks
Beschreibung

Section 11 Narrative Remarks

Alias
UMLS CUI-1
C3897642
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Beschreibung

Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)

Datentyp

text

Alias
UMLS CUI [1]
C3897642
Investigator's signature
Beschreibung

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator’s signature
Beschreibung

(confirming that the data on the SAE pages are accurate and complete)

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Beschreibung

Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Serious Adverse Events (SAE) Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
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])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Section 1
C1828479 (UMLS CUI-1)
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
Did the subject experience a serious adverse event during the study?
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])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
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])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
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])
Actions taken with Investigational Product(s) as a Result of the SAE
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])
Did the subject withdraw from study as a result of this SAE?
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])
Is there a reasonable possibility the SAE may have been caused by the investigational product?
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])
If fatal, was a post-mortem/autopsy performed
Code List
If fatal, was a post-mortem/autopsy performed
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Section 2 Seriousness
C1710056 (UMLS CUI-1)
Item
Specify reason(s) for considering this a SAE, tick all that apply:
text
C1710056 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specify reason(s) for considering this a SAE, tick all that apply:
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])
Item Group
Section 3 Demography Data
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Section 4
C0877248 (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])
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
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 Group
Section 5
C0015127 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s)
text
C0015127 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Possible Causes of SAE Other Than Investigational Product(s)
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])
If "Concomitant medication(s)", specify:
Item
If "Concomitant medication(s)", specify:
text
C2348235 (UMLS CUI [1,1])
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])
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])
Condition Present at Time of the SAE?
Code List
Condition Present at Time of the SAE?
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])
If No, Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
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])
Stop Date
Item
Stop Date
date
C2347852 (UMLS CUI [1,1])
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])
Item Group
Section 9 Details of Investigation Product(s)
C0013230 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Date of Dose
Item
Date of Dose
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dose
Item
Time of Dose
time
C0013227 (UMLS CUI [1,1])
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])
Item Group
Section 11 Narrative Remarks
C3897642 (UMLS CUI-1)
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])
Item Group
Investigator's signature
C2346576 (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])
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