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ID
38958
Description
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders
Keywords
Versions (1)
- 11/15/19 11/15/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 15, 2019
DOI
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Creative Commons BY-NC 3.0
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Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597
Concomitant Medications; Non-serious Adverse Events; Serious Adverse Events
Similar models
Concomitant Medications; Non-serious Adverse Events; Serious Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Concomitant Medication - Unit Dose
Item
Concomitant Medication - Unit Dose
float
C2347852 (UMLS CUI [1,1])
C0869039 (UMLS CUI [1,2])
C0869039 (UMLS CUI [1,2])
Item
Concomitant Medications - Units
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Concomitant Medication - Frequency
text
C2347852 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,2])
CL Item
1 x Daily (OD/QD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
Item
Concomitant Medication - Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Concomitant Medication - Reason for Medication
Item
Concomitant Medication - Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Conocmitant Medication - Start Date
Item
Conocmitant Medication - Start Date
date
C2826734 (UMLS CUI [1])
Conocmitant Medication - Start Time
Item
Conocmitant Medication - Start Time
time
C1301880 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Concomitant Medication - Taken prior to Study?
Item
Concomitant Medication - Taken prior to Study?
boolean
C2826667 (UMLS CUI [1])
Conocmitant Medication - Stop Date
Item
Conocmitant Medication - Stop Date
date
C2826744 (UMLS CUI [1])
Concomitant Medication - Stop Time
Item
Concomitant Medication - Stop Time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Concomitant Medication - Ongoing Medication?
Item
Concomitant Medication - Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Non-serious Adverse Event
Item
Non-serious Adverse Event
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event Start Date
Item
Non-serious Adverse Event Start Date
date
C2697888 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Non-serious Adverse Event Start Time
Item
Non-serious Adverse Event Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Item
Non-serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolvedmwith sequelae (4)
Non-serious Adverse Event End Date
Item
Non-serious Adverse Event End Date
date
C2697886 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Non-serious Adverse Event End Time
Item
Non-serious Adverse Event End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item
Non-serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Non-serious Adverse Event Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Did the subject experience a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Item Group
Serious Adverse Event - Section 1
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C2697888 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Start Time
Item
Serious Adverse Event Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolvedmwith sequelae (4)
CL Item
Fatal (5)
Serious Adverse Event End Date
Item
Serious Adverse Event End Date
date
C2697886 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item
Serious Adverse Event Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Action 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
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Did the subject withdraw from study as a result of this SAE?
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
If fatal, was a post-mortem/autopsy performed
Item
If fatal, was a post-mortem/autopsy performed
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item Group
Serious Adverse Event - Section 2 Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
C1710056 (UMLS CUI-2)
Item
Specify reason(s) for considering this a SAE
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a SAE
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation ( see definition of SAE ) (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify (F)
CL Item
Is associated with liver injury and impaired liver function (G)
If other reason for considering this a SAE, specify
Item
If other reason for considering this a SAE, specify
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Serious Adverse Event - Section 3 Demography Data
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
C0011298 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Female (F)
CL Item
Male (M)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Serious Adverse Event - Section 4
C1519255 (UMLS CUI-1)
Item
If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
Code List
If Investigational Product 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
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Section 5 Possible Causes of SAE Other Than Investigational Product(s)
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0085978 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Item
Possible Causes of SAE Other Than Investigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Code List
Possible Causes of SAE Other Than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) specify (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) s pecify (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
Specify medical conditions
Item
Specify medical conditions
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Specify concomitant medication(s)
Item
Specify concomitant medication(s)
text
C2347852 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
If other cause of SAE, specify
Item
If other cause of SAE, specify
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Serious Adverse Event - Section 6 Relevant medical Conditions
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C0012634 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
Specify any RELEVANT past or current medical disorders, allergies, surgeries that can help explain the SAE.
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries that can help explain the SAE.
text
C0012634 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1519255 (UMLS CUI [4])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1519255 (UMLS CUI [4])
Medical condition - Date of Onset
Item
Medical condition - Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Medical condition - Condition Present at Time of the SAE?
Item
Medical condition - Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If Condition is Present at Time of the SAE, Date of Last Occurence
Item
If Condition is Present at Time of the SAE, Date of Last Occurence
date
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1517741 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1517741 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
Item Group
Serious Adverse Event - Section 7 Other relevant Risk Factors
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Include details of any concomitant medication(s) that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
Item
Include details of any concomitant medication(s) that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
text
C2347852 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0681841 (UMLS CUI [2,2])
C0085978 (UMLS CUI [3,1])
C1519255 (UMLS CUI [3,2])
C2981656 (UMLS CUI [4,1])
C1519255 (UMLS CUI [4,2])
C1522508 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0681841 (UMLS CUI [2,2])
C0085978 (UMLS CUI [3,1])
C1519255 (UMLS CUI [3,2])
C2981656 (UMLS CUI [4,1])
C1519255 (UMLS CUI [4,2])
Item Group
Serious Adverse Event - Section 8 Relevant Concomitant Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
SAE Concomitant Medication - Drug Name
Item
SAE Concomitant Medication - Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
SAE Concomitant Medication - Dose
Item
SAE Concomitant Medication - Dose
float
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
SAE Concomitant Medication - Unit
Item
SAE Concomitant Medication - Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
SAE Concomitant Medication - Frequency
Item
SAE Concomitant Medication - Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
SAE Concomitant Medication - Route
Item
SAE Concomitant Medication - Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
SAE Concomitant Medication - Taken Prior to Study?
Item
SAE Concomitant Medication - Taken Prior to Study?
boolean
C1519255 (UMLS CUI [1,1])
C2826667 (UMLS CUI [1,2])
C2826667 (UMLS CUI [1,2])
SAE Concomitant Medication - Start Date
Item
SAE Concomitant Medication - Start Date
date
C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
C2826734 (UMLS CUI [1,2])
SAE Concomitant Medication - Stop Date
Item
SAE Concomitant Medication - Stop Date
date
C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,2])
SAE Concomitant Medication - Ongoing Medication?
Item
SAE Concomitant Medication - Ongoing Medication?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,2])
SAE Concomitant Medication - Reason for Medication
Item
SAE Concomitant Medication - Reason for Medication
text
C1519255 (UMLS CUI [1,1])
C2826696 (UMLS CUI [1,2])
C2826696 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Section 9 Details of Investigational Product(s)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Details of Investigational Product(s)
Item
Details of Investigational Product(s)
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item
Was treatment blind broken at investigational site?
text
C3897431 (UMLS CUI [1])
Code List
Was treatment blind broken at investigational site?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Section 10 Details of relevant Assessments
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Details of relevant Assessments
Item
Details of relevant Assessments
text
C0220825 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Section 11 Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI-2)
Serious Adverse Event - Narrative Remarks
Item
Serious Adverse Event - Narrative Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator’s name (print)
Item
Investigator’s name (print)
text
C2826892 (UMLS CUI [1])
Investigator's signature - Date
Item
Investigator's signature - Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])