ID
20711
Description
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
Keywords
Versions (1)
- 3/13/17 3/13/17 -
Uploaded on
March 13, 2017
DOI
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License
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
Description
Section 1
Alias
- UMLS CUI-1
- C1828479
Description
If Yes, record details below.
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Start Date
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Description
Start Time
Data type
time
Measurement units
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C1519255
Description
Outcome
Data type
text
Alias
- UMLS CUI [1]
- C1705586
Description
If fatal, record date of death.
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Description
End Time
Data type
time
Measurement units
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Description
Maximum Intensity
Data type
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Description
Actions taken with Investigational Product(s) as a Result of the SAE
Data type
text
Alias
- UMLS CUI [1]
- C1704758
Description
Did the subject withdraw from study as a result of this SAE?
Data type
text
Alias
- UMLS CUI [1]
- C0422727
Description
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Data type
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
Description
If Yes, summarize findings in Section 11 Narrative Remarks of this SAE form.
Data type
text
Alias
- UMLS CUI [1]
- C0004398
Description
Section 2 Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
Specify reason(s) for considering this a SAE, tick all that apply:
Data type
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C2348235
Description
If Other, specify:
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C1710056
Description
Section 3 Demography Data
Alias
- UMLS CUI-1
- C0011298
Description
Section 4
Alias
- UMLS CUI-1
- C0877248
Description
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Data type
text
Alias
- UMLS CUI [1]
- C2826663
Description
Section 5
Alias
- UMLS CUI-1
- C0015127
- UMLS CUI-2
- C1519255
Description
Possible Causes of SAE Other Than Investigational Product(s)
Data type
text
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C1519255
Description
If
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0012634
Description
If "Concomitant medication(s)", specify:
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C2347852
Description
If "Other", specify:
Data type
text
Alias
- UMLS CUI [1]
- C2348235
Description
Section 6 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Description
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1519255
Description
Date of Onset
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1]
- C0574845
Description
Condition Present at Time of the SAE?
Data type
text
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Description
If No, Date of Last Occurrence
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Description
If No, Date of Last Occurrence
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Description
Section 7 Other RELEVANT Risk Factors
Alias
- UMLS CUI-1
- C0035648
Description
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Data type
text
Alias
- UMLS CUI [1]
- C0035648
Description
Section 8 RELEVANT Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Description
Trade Name preferred
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Dose
Data type
float
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C2348328
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Taken Prior to Study
Data type
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Start Date
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0808070
Description
Stop Date
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0806020
Description
Ongoing Medication?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Section 9 Details of Investigation Product(s)
Alias
- UMLS CUI-1
- C0013230
- UMLS CUI-2
- C1522508
Description
Section 10 Details of RELEVANT Assessments
Alias
- UMLS CUI-1
- C1261322
Description
Section 11 Narrative Remarks
Alias
- UMLS CUI-1
- C3897642
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
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