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41545
Beschreibung
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2
Stichworte
Versionen (2)
- 04.11.20 04.11.20 -
- 29.11.20 29.11.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
4. November 2020
DOI
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Lizenz
Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692
Adverse Events/ Serious Adverse Events; Prior and Concomitant Medications/ Non-drug Therapies
Ähnliche Modelle
Adverse Events/ Serious Adverse Events; Prior and Concomitant Medications/ Non-drug Therapies
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc #
Item
Doc #
text
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
C0750479 (UMLS CUI [1,2])
Has the Subject experienced any adverse events?
Item
Has the Subject experienced any adverse events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Adverse Events/ Serious Adverse Events - Section 1
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI-2)
Adverse Event Number
Item
Adverse Event Number
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
CL Item
Liver (1)
CL Item
Cardiovascular (2)
CL Item
GI (3)
CL Item
Thyroid (4)
CL Item
Hypoglycemic (5)
CL Item
Injection site reaction (6)
CL Item
Diabetic retinopathy (7)
CL Item
Other (8)
Adverse Event Start Date
Item
Adverse Event Start Date
date
C2697888 (UMLS CUI [1])
CL Item
Fatal (1)
CL Item
Recovered/resolved with sequelae (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovering/resolving (4)
CL Item
Recovered/resolved (5)
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
Item
Adverse Event Maximum Intensity
integer
C0877248 (UMLS CUI [1])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
CL Item
Not applicable (1)
CL Item
Severe (2)
CL Item
Moderate (3)
CL Item
Mild (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Not applicable (3)
Withdrawal (Did the subject withdraw from study as a result of this AE?)
Item
Withdrawal (Did the subject withdraw from study as a result of this AE?)
boolean
C1710677 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Item
Relationship to Investigational Product(s)
boolean
C0877248 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0439849 (UMLS CUI [3])
C0013230 (UMLS CUI [2])
C0439849 (UMLS CUI [3])
Was a concomitant medication/non-drug therapy taken for this AE?
Item
Was a concomitant medication/non-drug therapy taken for this AE?
boolean
C2347852 (UMLS CUI [1])
C0599938 (UMLS CUI [2])
C0877248 (UMLS CUI [3])
C0599938 (UMLS CUI [2])
C0877248 (UMLS CUI [3])
Was event serious?
Item
Was event serious?
boolean
C1519255 (UMLS CUI [1])
Item Group
Adverse Events/ Serious Adverse Events - Section 2 (Seriousness)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1710056 (UMLS CUI-3)
C1519255 (UMLS CUI-2)
C1710056 (UMLS CUI-3)
Item
Specify reason(s) for considering this a SAE, check all that apply
text
C1519255 (UMLS CUI [1])
C0566251 (UMLS CUI [2])
C0566251 (UMLS CUI [2])
Code List
Specify reason(s) for considering this a SAE, check 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, specify (F)
Specify other reason for considering this a SAE
Item
Specify other reason for considering this a SAE
text
C1519255 (UMLS CUI [1])
C0566251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0566251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Item Group
Adverse Events/ Serious Adverse Events - Section 3 (Demography Data)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0011298 (UMLS CUI-3)
C1519255 (UMLS CUI-2)
C0011298 (UMLS CUI-3)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Sex
Item
Sex
text
C0079399 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Adverse Events/ Serious Adverse Events - Section 4
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI-2)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C1519255 (UMLS CUI [1])
C0034897 (UMLS CUI [2])
C0304229 (UMLS CUI [3])
C0457454 (UMLS CUI [4])
C0034897 (UMLS CUI [2])
C0304229 (UMLS CUI [3])
C0457454 (UMLS CUI [4])
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (NA)
Item Group
Adverse Events/ Serious Adverse Events - Section 5
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s), check all that apply:
integer
C1519255 (UMLS CUI [1])
C0085978 (UMLS CUI [2])
C0304229 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0085978 (UMLS CUI [2])
C0304229 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Code List
Possible Causes of SAE Other Than Investigational Product(s), check all that apply:
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 specify (7)
Item Group
Adverse Events/ Serious Adverse Events - Section 6 (Medical Conditions)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C1519255 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
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
C0012634 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C2347946 (UMLS CUI [4])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C2347946 (UMLS CUI [4])
Serious Adverse Event - Date of Onset
Item
Serious Adverse Event - Date of Onset
date
C1519255 (UMLS CUI [1])
C2985916 (UMLS CUI [2])
C2985916 (UMLS CUI [2])
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
If condition not present at Time of SAE, enter date of Last Occurence
Item
If condition not present at Time of SAE, enter date of Last Occurence
date
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C2745955 (UMLS CUI [3,1])
C1517741 (UMLS CUI [3,2])
C0011008 (UMLS CUI [3,3])
C1519255 (UMLS CUI [2])
C2745955 (UMLS CUI [3,1])
C1517741 (UMLS CUI [3,2])
C0011008 (UMLS CUI [3,3])
Item Group
Adverse Events/ Serious Adverse Events - Section 7 (Other RELEVANT Risk Factors)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C2347946 (UMLS CUI-5)
C1519255 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C2347946 (UMLS CUI-5)
Provide any family or social history (e.g. smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
Item
Provide any family or social history (e.g. smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
text
C0241889 (UMLS CUI [1])
C3714536 (UMLS CUI [2])
C1519384 (UMLS CUI [3])
C0001948 (UMLS CUI [4])
C0012155 (UMLS CUI [5])
C0013146 (UMLS CUI [6])
C0337074 (UMLS CUI [7])
C1519255 (UMLS CUI [8])
C3714536 (UMLS CUI [2])
C1519384 (UMLS CUI [3])
C0001948 (UMLS CUI [4])
C0012155 (UMLS CUI [5])
C0013146 (UMLS CUI [6])
C0337074 (UMLS CUI [7])
C1519255 (UMLS CUI [8])
Other RELEVANT Risk Factors
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2347946 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2347946 (UMLS CUI [3])
Item Group
Adverse Events/ Serious Adverse Events - Section 8 (RELEVANT Concomitant Medications)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C2347852 (UMLS CUI-3)
C2347946 (UMLS CUI-4)
C1519255 (UMLS CUI-2)
C2347852 (UMLS CUI-3)
C2347946 (UMLS CUI-4)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Medication Dose
Item
Medication Dose
float
C3174092 (UMLS CUI [1])
Medication Unit
Item
Medication Unit
text
C2826646 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Other Route, specify
Item
Other Route, specify
text
C0013153 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Medication Taken Prior to study
Item
Medication Taken Prior to study
boolean
C2826667 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Item Group
Adverse Events/ Serious Adverse Events - Section 9 (Details of Investigational Product(s))
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
C1519255 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
Details of Investigational Product(s)
Item
Details of Investigational Product(s)
text
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Item Group
Adverse Events/ Serious Adverse Events - Section 10 (Details of RELEVANT ASSESSMENTS)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C2347946 (UMLS CUI-4)
C1519255 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C2347946 (UMLS CUI-4)
Details of RELEVANT ASSESSMENTS
Item
Details of RELEVANT ASSESSMENTS
text
C0220825 (UMLS CUI [1])
C1522508 (UMLS CUI [2])
C2347946 (UMLS CUI [3])
C1522508 (UMLS CUI [2])
C2347946 (UMLS CUI [3])
Item Group
Adverse Events/ Serious Adverse Events - Section 11 (Narrative Remarks)
C0877248 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
C0947611 (UMLS CUI-3)
C1519255 (UMLS CUI-2)
C0947611 (UMLS CUI-3)
Item Group
Prior and Concomitant Medications/Non-drug Therapies
C2347852 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C0033082 (UMLS CUI-3)
C0087111 (UMLS CUI-4)
C1514463 (UMLS CUI-2)
C0033082 (UMLS CUI-3)
C0087111 (UMLS CUI-4)
Did Subject participate in any Non-Drug Therapies or take Concomitant medications within 30 days prior to screening and/or during the study?
Item
Did Subject participate in any Non-Drug Therapies or take Concomitant medications within 30 days prior to screening and/or during the study?
boolean
C0087111 (UMLS CUI [1,1])
C0033082 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
C0033082 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Item Group
Prior and Concomitant Medications/Non-drug Therapies
C2347852 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C0033082 (UMLS CUI-3)
C0087111 (UMLS CUI-4)
C1514463 (UMLS CUI-2)
C0033082 (UMLS CUI-3)
C0087111 (UMLS CUI-4)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Medication Unit Dose
Item
Medication Unit Dose
text
C2826646 (UMLS CUI [1])
Medication Unit
Item
Medication Unit
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Specify other Medication Route
Item
Specify other Medication Route
text
C0013153 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
AE/SAE #
Item
AE/SAE #
text
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Mark if medication is continuing
Item
Mark if medication is continuing
boolean
C2347852 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Medicatino taken prior to study?
Item
Medicatino taken prior to study?
boolean
C2826667 (UMLS CUI [1])