ID
39190
Beskrivning
Study ID: 103106 Clinical Study ID: WXL103106 Study Title:An open-label, 2-period, sequential treatment, 1-way drug interaction study to evaluate the effect of ritonavir on bupropion pharmacokinetics in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: bupropion Trade Name: Wellbutrin,QUOMEM,Elontril,Zyban,ZYNTABAC; Zyban,ZYNTABAC,Wellbutrin,Wellburin,QUOMEM,Prolev,Magerion,Geronplase,Elontril Study Indication: Depressive Disorder
Nyckelord
Versioner (1)
- 2019-12-08 2019-12-08 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
8 december 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Effect of Ritonavir on Bupropion Pharmacokinetics; 103106
Serious Adverse Event (SAE)
- StudyEvent: ODM
Beskrivning
Section 1
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Serious Adverse Event, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Beskrivning
Serious Adverse Event, Start Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Beskrivning
Serious Adverse Event, Adverse Event Outcome
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beskrivning
Serious Adverse Event, End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Beskrivning
Serious Adverse Event, End Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Beskrivning
Serious Adverse Event, Symptom Intensity, Maximum
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Serious Adverse Event, Action Taken with Study Treatment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Beskrivning
Serious Adverse Event, Withdraw
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Beskrivning
Serious Adverse Event, Relationships, Experimental drug
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beskrivning
Serious Adverse Event, Fatal, Autopsy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Beskrivning
Section 2: Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beskrivning
Serious Adverse Event, Seriousness of Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Beskrivning
Serious Adverse Event, Seriousness of Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710056
Beskrivning
Serious 3: Demography Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0011298
Beskrivning
Serious Adverse Event, Patient date of birth
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0421451
Beskrivning
Serious Adverse Event, Gender
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0079399
Beskrivning
Serious Adverse Event, Body Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0005910
Beskrivning
Section 4: If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0439849
- UMLS CUI-3
- C0304229
Beskrivning
Section 5: Possible Causes of SAE Other Than Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0015127
Beskrivning
Serious Adverse Event, Etiology aspects
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Beskrivning
Section 6: Relevant Medical Conditions
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
Beskrivning
Serious Adverse Event, Disease; Serious Adverse Event, Hypersensitivity; Serious Adverse Event, Operative Surgical Procedures
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0020517
- UMLS CUI [3,1]
- C1519255
- UMLS CUI [3,2]
- C0543467
Beskrivning
Serious Adverse Event, Disease, Start Date; Serious Adverse Event, Hypersensitivity, Start Date; Serious Adverse Event, Operative Surgical Procedures, Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0020517
- UMLS CUI [2,3]
- C0808070
- UMLS CUI [3,1]
- C1519255
- UMLS CUI [3,2]
- C0543467
- UMLS CUI [3,3]
- C0808070
Beskrivning
Serious Adverse Event, Disease, End Date; Serious Adverse Event, Hypersensitivity, End Date; Serious Adverse Event, Operative Surgical Procedures, End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0806020
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0020517
- UMLS CUI [2,3]
- C0806020
- UMLS CUI [3,1]
- C1519255
- UMLS CUI [3,2]
- C0543467
- UMLS CUI [3,3]
- C0806020
Beskrivning
Section 7: Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
Beskrivning
Section 8: Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beskrivning
Serious Adverse Event, Concomitant Agent, Medication name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Beskrivning
Serious Adverse Event, Concomitant Agent, Dosage
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0178602
Beskrivning
Serious Adverse Event, Concomitant Agent, Unit of Measure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519795
Beskrivning
Serious Adverse Event, Concomitant Agent, Frequencies
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439603
Beskrivning
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Beskrivning
Serious Adverse Event, Concomitant Medication Previous Occurrence
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826667
Beskrivning
Serious Adverse Event, Concomitant Medication Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826734
Beskrivning
Serious Adverse Event, Concomitant Medication End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826744
Beskrivning
Serious Adverse Event, Concomitant Medication Ongoing
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826666
Beskrivning
Serious Adverse Event, Concomitant Agent, Reason and justification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0566251
Beskrivning
Section 9: Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1522508
Beskrivning
Serious Adverse Event, Experimental drug
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
Beskrivning
Serious Adverse Event, Experimental drug, Dosage, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0011008
Beskrivning
Serious Adverse Event, Experimental drug, Dosage, Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0040223
Beskrivning
Serious Adverse Event, Experimental drug, Subject Unblinding Event Record
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C3897431
Beskrivning
Section 10: Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
Beskrivning
Section 11: Narrative Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beskrivning
Investigator's Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Beskrivning
Serious Adverse Event, Investigator Signature
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
Beskrivning
Serious Adverse Event, Investigator Signature, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
- UMLS CUI [1,3]
- C0011008
Beskrivning
Serious Adverse Event, Investigator Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826892
Similar models
Serious Adverse Event (SAE)
- StudyEvent: ODM
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1704758 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C1710056 (UMLS CUI-2)
C1710056 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C0011298 (UMLS CUI-2)
C0421451 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,2])
C0439849 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0015127 (UMLS CUI-2)
C0015127 (UMLS CUI [1,2])
C0012634 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0808070 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0808070 (UMLS CUI [3,3])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0806020 (UMLS CUI [2,3])
C1519255 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0806020 (UMLS CUI [3,3])
C0035648 (UMLS CUI-2)
C0035648 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439603 (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])
C2347852 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
C0430022 (UMLS CUI-2)
C0430022 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI [1,2])
C2346576 (UMLS CUI-2)
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2826892 (UMLS CUI [1,2])