ID
38958
Beskrivning
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
Nyckelord
Versioner (1)
- 15-11-19 15-11-19 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 november 2019
DOI
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Licens
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
Beskrivning
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Concomitant Medication - Unit Dose
Datatyp
float
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0869039
Beskrivning
Concomitant Medications - Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
Beskrivning
Concomitant Medication - Frequency
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3476109
Beskrivning
Concomitant Medication - Route
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Beskrivning
Concomitant Medication - Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0013227
Beskrivning
Conocmitant Medication - Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
Conocmitant Medication - Start Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Beskrivning
Concomitant Medication - Taken prior to Study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beskrivning
Conocmitant Medication - Stop Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Concomitant Medication - Stop Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1522314
Beskrivning
Concomitant Medication - Ongoing Medication?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Non-Serious adverse Events
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Non-Serious adverse Events
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Non-serious Adverse Event Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C1518404
Beskrivning
Non-serious Adverse Event Start Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Beskrivning
Non-serious Adverse Event Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beskrivning
Non-serious Adverse Event End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2697886
- UMLS CUI [1,2]
- C1518404
Beskrivning
Non-serious Adverse Event End Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Beskrivning
Non-serious Adverse Event Frequency
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beskrivning
Non-serious Adverse Event Maximum Intensity
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beskrivning
Did the subject withdraw from study as a result of this AE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beskrivning
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event - Section 1
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Diagnosis Only (if known ) Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Serious Adverse Event Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C1519255
Beskrivning
Serious Adverse Event Start Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Beskrivning
Serious Adverse Event Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beskrivning
Serious Adverse Event End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2697886
- UMLS CUI [1,2]
- C1519255
Beskrivning
Serious Adverse Event End Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Beskrivning
Serious Adverse Event Maximum Intensity
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Action Taken with Investigational Product(s) as a Result of the SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
Did the subject withdraw from study as a result of this SAE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beskrivning
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Beskrivning
Serious Adverse Event - Section 2 Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beskrivning
Check all that apply:
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
Beskrivning
If other reason for considering this a SAE, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Serious Adverse Event - Section 3 Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0011298
Beskrivning
Serious Adverse Event - Section 4
Alias
- UMLS CUI-1
- C1519255
Beskrivning
If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) Were Administered?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0457454
Beskrivning
Serious Adverse Event - Section 5 Possible Causes of SAE Other Than Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
- UMLS CUI-3
- C0304229
- UMLS CUI-4
- C0205394
Beskrivning
Check all that apply:
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0205394
Beskrivning
Specify medical conditions
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
Specify concomitant medication(s)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348235
Beskrivning
If other cause of SAE, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Serious Adverse Event - Section 6 Relevant medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C2347946
Beskrivning
Ensure each medical condition recorded in this section is also recorded in the appropriate Medical Conditions form
Datatyp
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0020517
- UMLS CUI [3]
- C0543467
- UMLS CUI [4]
- C1519255
Beskrivning
Medical condition - Date of Onset
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beskrivning
Medical condition - Condition Present at Time of the SAE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Beskrivning
If Condition is Present at Time of the SAE, Date of Last Occurence
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2,1]
- C1517741
- UMLS CUI [2,2]
- C2745955
- UMLS CUI [2,3]
- C0011008
Beskrivning
Serious Adverse Event - Section 7 Other relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
Beskrivning
Ensure each concomitant medication recorded in this section is also recorded in the Concomitant Medication form.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1522508
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0681841
- UMLS CUI [3,1]
- C0085978
- UMLS CUI [3,2]
- C1519255
- UMLS CUI [4,1]
- C2981656
- UMLS CUI [4,2]
- C1519255
Beskrivning
Serious Adverse Event - Section 8 Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Beskrivning
SAE Concomitant Medication - Dose
Datatyp
float
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Beskrivning
SAE Concomitant Medication - Unit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439148
Beskrivning
SAE Concomitant Medication - Frequency
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3476109
Beskrivning
SAE Concomitant Medication - Route
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Beskrivning
SAE Concomitant Medication - Taken Prior to Study?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826667
Beskrivning
SAE Concomitant Medication - Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826734
Beskrivning
SAE Concomitant Medication - Stop Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826744
Beskrivning
SAE Concomitant Medication - Ongoing Medication?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826666
Beskrivning
SAE Concomitant Medication - Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826696
Beskrivning
Serious Adverse Event - Section 9 Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1522508
Beskrivning
Details of Investigational Product(s)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1522508
Beskrivning
Was treatment blind broken at investigational site?
Datatyp
text
Alias
- UMLS CUI [1]
- C3897431
Beskrivning
Serious Adverse Event - Section 10 Details of relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C1522508
Beskrivning
Provide details of any tests or procedures carried out to diagnose or confirm the SAE (e.g., laboratory data with units and normal range) if data for this SAE have not been previously entered, and the CRF includes a page for the test, ensure the data is also entered on the page.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C1522508
Beskrivning
Serious Adverse Event - Section 11 Narrative Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beskrivning
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
(confirming that the data on the SAE pages are accurate and complete)
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator’s name (print)
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Investigator's signature - Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Concomitant Medications; Non-serious Adverse Events; Serious Adverse Events
C0019994 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0869039 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C1710056 (UMLS CUI-2)
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0011298 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
C0085978 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0012634 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1519255 (UMLS CUI [4])
C0574845 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
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])
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
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])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2826667 (UMLS CUI [1,2])
C2826734 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,2])
C2826696 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C1522508 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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