ID
20711
Beschrijving
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
Trefwoorden
Versies (1)
- 13-03-17 13-03-17 -
Geüploaded op
13 maart 2017
DOI
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Licentie
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
Beschrijving
Section 1
Alias
- UMLS CUI-1
- C1828479
Beschrijving
If Yes, record details below.
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Start Date
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Beschrijving
Start Time
Datatype
time
Maateenheden
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C1519255
Beschrijving
Outcome
Datatype
text
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
If fatal, record date of death.
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Beschrijving
End Time
Datatype
time
Maateenheden
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Beschrijving
Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beschrijving
Actions taken with Investigational Product(s) as a Result of the SAE
Datatype
text
Alias
- UMLS CUI [1]
- C1704758
Beschrijving
Did the subject withdraw from study as a result of this SAE?
Datatype
text
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Datatype
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
Beschrijving
If Yes, summarize findings in Section 11 Narrative Remarks of this SAE form.
Datatype
text
Alias
- UMLS CUI [1]
- C0004398
Beschrijving
Section 2 Seriousness
Alias
- UMLS CUI-1
- C1710056
Beschrijving
Specify reason(s) for considering this a SAE, tick all that apply:
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C2348235
Beschrijving
If Other, specify:
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C1710056
Beschrijving
Section 3 Demography Data
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Section 4
Alias
- UMLS CUI-1
- C0877248
Beschrijving
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Datatype
text
Alias
- UMLS CUI [1]
- C2826663
Beschrijving
Section 5
Alias
- UMLS CUI-1
- C0015127
- UMLS CUI-2
- C1519255
Beschrijving
Possible Causes of SAE Other Than Investigational Product(s)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C1519255
Beschrijving
If
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0012634
Beschrijving
If "Concomitant medication(s)", specify:
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C2347852
Beschrijving
If "Other", specify:
Datatype
text
Alias
- UMLS CUI [1]
- C2348235
Beschrijving
Section 6 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Beschrijving
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1519255
Beschrijving
Date of Onset
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Condition Present at Time of the SAE?
Datatype
text
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Beschrijving
If No, Date of Last Occurrence
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Beschrijving
If No, Date of Last Occurrence
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Beschrijving
Section 7 Other RELEVANT Risk Factors
Alias
- UMLS CUI-1
- C0035648
Beschrijving
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Datatype
text
Alias
- UMLS CUI [1]
- C0035648
Beschrijving
Section 8 RELEVANT Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Trade Name preferred
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Dose
Datatype
float
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C2348328
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Taken Prior to Study
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschrijving
Start Date
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0808070
Beschrijving
Stop Date
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0806020
Beschrijving
Ongoing Medication?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
Section 9 Details of Investigation Product(s)
Alias
- UMLS CUI-1
- C0013230
- UMLS CUI-2
- C1522508
Beschrijving
Section 10 Details of RELEVANT Assessments
Alias
- UMLS CUI-1
- C1261322
Beschrijving
Section 11 Narrative Remarks
Alias
- UMLS CUI-1
- C3897642
Beschrijving
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
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