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
Lien
https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1
Mots-clés
Versions (1)
- 13/03/2017 13/03/2017 -
Téléchargé le
13 mars 2017
DOI
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Licence
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.
Type de données
text
Alias
- UMLS CUI [1]
- C1519255
Description
Start Date
Type de données
date
Unités de mesure
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Description
Start Time
Type de données
time
Unités de mesure
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C1519255
Description
Outcome
Type de données
text
Alias
- UMLS CUI [1]
- C1705586
Description
If fatal, record date of death.
Type de données
date
Unités de mesure
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Description
End Time
Type de données
time
Unités de mesure
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Description
Maximum Intensity
Type de données
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
Type de données
text
Alias
- UMLS CUI [1]
- C1704758
Description
Did the subject withdraw from study as a result of this SAE?
Type de données
text
Alias
- UMLS CUI [1]
- C0422727
Description
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Type de données
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.
Type de données
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:
Type de données
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C2348235
Description
If Other, specify:
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C1710056
Description
Section 3 Demography Data
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Type de données
date
Unités de mesure
- Day Month Year
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
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?
Type de données
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)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C1519255
Description
If
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0012634
Description
If "Concomitant medication(s)", specify:
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C2347852
Description
If "Other", specify:
Type de données
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
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1519255
Description
Date of Onset
Type de données
date
Unités de mesure
- Day Month Year
Alias
- UMLS CUI [1]
- C0574845
Description
Condition Present at Time of the SAE?
Type de données
text
Alias
- UMLS CUI [1,1]
- C3827351
- UMLS CUI [1,2]
- C1519255
Description
If No, Date of Last Occurrence
Type de données
date
Unités de mesure
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Description
If No, Date of Last Occurrence
Type de données
date
Unités de mesure
- 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)
Type de données
text
Alias
- UMLS CUI [1]
- C0035648
Description
Section 8 RELEVANT Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Description
Trade Name preferred
Type de données
text
Alias
- UMLS CUI [1]
- C0013227
Description
Dose
Type de données
float
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Type de données
text
Alias
- UMLS CUI [1]
- C2348328
Description
Frequency
Type de données
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Type de données
text
Alias
- UMLS CUI [1]
- C0013153
Description
Taken Prior to Study
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Start Date
Type de données
date
Unités de mesure
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0808070
Description
Stop Date
Type de données
date
Unités de mesure
- Day Month Year
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0806020
Description
Ongoing Medication?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Medication
Type de données
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
Date of Dose
Type de données
date
Unités de mesure
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0011008
Description
Time of Dose
Type de données
time
Unités de mesure
- Hr : Min
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0040223
Description
Section 10 Details of RELEVANT Assessments
Alias
- UMLS CUI-1
- C1261322
Description
Details of RELEVANT Assessments
Type de données
text
Alias
- UMLS CUI [1,1]
- C1261322
- UMLS CUI [1,2]
- C1522508
Description
Section 11 Narrative Remarks
Alias
- UMLS CUI-1
- C3897642
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Similar models
Serious Adverse Events (SAE) Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
C0019994 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C1522508 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])