ID
42297
Beschrijving
Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension
Trefwoorden
Versies (1)
- 10-05-21 10-05-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
10 mei 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533)
Logs and Repeats: Adverse Events; Concomitant Medications; ECG; Vital Signs; Pharmacokinetics
Beschrijving
Date of visit/assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Beschrijving
Adverse Event/ Concomitant Medication/Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-3
- C2347852
- UMLS CUI-5
- C0205341
- UMLS CUI-6
- C0220825
Beschrijving
Were any concomitant medications taken by the subject during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Did the subject experience any adverse events during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Were any repeat ECGs performed?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beschrijving
Did the subject have any abnormal ECGs during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0522055
Beschrijving
Were any repeat vital signs recorded?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beschrijving
Were any repeat Orthostatic Vital Signs recorded?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1827287
- UMLS CUI [1,2]
- C0205341
Beschrijving
Were any repeat PK taken?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0205341
Beschrijving
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Adverse Events Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348184
Beschrijving
Diagnosis (if known), otherwise sign/symptom.
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Adverse Event Modified Term
Datatype
text
Alias
- UMLS CUI [1]
- C2826798
Beschrijving
Adverse Event MedDRA synonym
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C1140263
Beschrijving
Adverse Event MedDRA lower level term code
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C3898442
Beschrijving
Adverse Event Failed coding
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2,1]
- C0805701
- UMLS CUI [2,2]
- C0231175
Beschrijving
Adverse Event Start Date and Time
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826806
Beschrijving
Adverse Event Outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Adverse Event End Date and Time
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschrijving
Adverse Event Frequency
Datatype
integer
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C0439603
Beschrijving
Adverse Event Maximum Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
Action Taken with Investigational Product(s) as a Result of the AE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C0877248
Beschrijving
Did the subject withdraw from study as a result of this AE?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1710677
- UMLS CUI [2]
- C0877248
Beschrijving
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C0013230
- UMLS CUI [3]
- C0439849
Beschrijving
If "Yes", complete paper SAE form.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1710056
Beschrijving
If Adverse Event is serious, chack all that apply
Datatype
integer
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Specify other reason for serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [2]
- C2348235
Beschrijving
Was this SAE caused by an activity related to study participation (e.g., procedures)?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2]
- C0441655
- UMLS CUI [3]
- C2348568
Beschrijving
Serious Flag
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205404
- UMLS CUI [1,2]
- C1708067
Beschrijving
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant Medications Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beschrijving
Trade Name preferred
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschrijving
Concomitant Medications Modified reported term
Datatype
text
Alias
- UMLS CUI [1]
- C2826819
Beschrijving
Concomitant Medications GSK Drug synonym
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0871468
Beschrijving
Concomitant Medications GSK Drug Collection Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [2]
- C0011008
Beschrijving
Concomitant Medications Failed coding
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0805701
- UMLS CUI [2,2]
- C0231175
Beschrijving
Concomitant Medications Unit Dose
Datatype
text
Alias
- UMLS CUI [1]
- C2826646
Beschrijving
Concomitant Medications Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
Beschrijving
Concomitant Medications Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
- UMLS CUI [2]
- C2347852
Beschrijving
Concomitant Medicaton Routes
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0013153
Beschrijving
Concomitant Medications Reason for Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3146298
Beschrijving
Concomitant Medications Start Date and Time
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826825
Beschrijving
Concomitant Medication Taken Prior to Study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschrijving
Concomitant Medications Ongoing?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
If Concomitant Medications not Ongoing, specify End Date and Time
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826815
Beschrijving
12-Lead/ Holter/ Telemetry ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-3
- C0013801
- UMLS CUI-5
- C1623258
- UMLS CUI-6
- C0039451
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
Record clinically significant abnormalities. Check all that apply.
Datatype
text
Alias
- UMLS CUI [1]
- C0232187
Beschrijving
Other abnormal rhythm
Datatype
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [2]
- C0205394
Beschrijving
B. P-Wave Morphology
Datatype
integer
Alias
- UMLS CUI [1]
- C2216025
Beschrijving
Other morphology
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beschrijving
C: Conduction
Datatype
text
Alias
- UMLS CUI [1]
- C0232217
Beschrijving
Other conduction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
Beschrijving
D. Myocardial Infarction
Datatype
integer
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Other myocardial infarction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
Beschrijving
E. Depolarisation/Repolarisation (QRS-T)
Datatype
integer
Alias
- UMLS CUI [1]
- C1395184
- UMLS CUI [2]
- C0948857
Beschrijving
Other depolarisation/ repolarisation
Datatype
text
Alias
- UMLS CUI [1,1]
- C2746082
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C0948857
- UMLS CUI [2,2]
- C0205394
Beschrijving
Other abnormalities, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C0947611
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Actual date/ time (Vital Signs)
Datatype
datetime
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C1264639
Beschrijving
Subject position (Vital Signs)
Datatype
integer
Alias
- UMLS CUI [1]
- C1262869
- UMLS CUI [2]
- C0518766
Beschrijving
Systolic blood pressure (Vital Signs)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0871470
Beschrijving
Diastolic blood pressure (Vital Signs)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0428883
Beschrijving
Blood pressure not done (Vital Signs)
Datatype
integer
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0005823
- UMLS CUI [3]
- C1272696
Beschrijving
Heart rate (Vital Signs)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0018810
Beschrijving
Heart rate not done (Vital Signs)
Datatype
integer
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C0518766
- UMLS CUI [3]
- C1272696
Beschrijving
Pharmacokinetics
Alias
- UMLS CUI-1
- C0031328
Beschrijving
Orthostatic Vital Signs
Alias
- UMLS CUI-1
- C1827287
Beschrijving
Actual date/time (Orthostatic Vital Signs)
Datatype
datetime
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C1264639
Beschrijving
Subject position (Orthostatic Vital Signs)
Datatype
integer
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C1262869
Beschrijving
Systolic blood pressure (Orthostatic Vital Signs)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C0871470
Beschrijving
Diastolic blood pressure (Orthostatic Vital Signs)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C0428883
Beschrijving
Blood pressure not done (Orthostatic Vital Signs)
Datatype
integer
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C0005823
- UMLS CUI [3]
- C1272696
Beschrijving
Heart rate (Orthostatic Vital Signs)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C0018810
Beschrijving
Heart rate not done (Orthostatic Vital Signs)
Datatype
integer
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C1272696
Similar models
Logs and Repeats: Adverse Events; Concomitant Medications; ECG; Vital Signs; Pharmacokinetics
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C2347852 (UMLS CUI-3)
C0205341 (UMLS CUI-5)
C0220825 (UMLS CUI-6)
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C1140263 (UMLS CUI [2])
C3898442 (UMLS CUI [2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0439603 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2])
C0013230 (UMLS CUI [2])
C0439849 (UMLS CUI [3])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C1708067 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0871468 (UMLS CUI [2,2])
C1516698 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C1519795 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
C0013153 (UMLS CUI [2])
C3146298 (UMLS CUI [1,2])
C0013801 (UMLS CUI-3)
C1623258 (UMLS CUI-5)
C0039451 (UMLS CUI-6)
C1704258 (UMLS CUI-2)
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0332437 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
C1264639 (UMLS CUI [2])
C0518766 (UMLS CUI [2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [2])
C0005823 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
C0018810 (UMLS CUI [2])
C0518766 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
C1264639 (UMLS CUI [2])
C1264639 (UMLS CUI [2])
C1262869 (UMLS CUI [2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [2])
C0005823 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
C0018810 (UMLS CUI [2])
C1827287 (UMLS CUI [2])
C1272696 (UMLS CUI [3])