ID

42297

Beschreibung

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

Stichworte

Versionen (1)
  1. 10.05.21 10.05.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Mai 2021

DOI

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Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533)

Englisch

Logs and Repeats: Adverse Events; Concomitant Medications; ECG; Vital Signs; Pharmacokinetics

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Beschreibung

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beschreibung

Date of visit/assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Adverse Event/ Concomitant Medication/Repeat Assessment Check Questions
Beschreibung

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
Were any concomitant medications taken by the subject during the study?
Beschreibung

Were any concomitant medications taken by the subject during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any adverse events during the study?
Beschreibung

Did the subject experience any adverse events during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Were any repeat ECGs performed?
Beschreibung

Were any repeat ECGs performed?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
Did the subject have any abnormal ECGs during the study?
Beschreibung

Did the subject have any abnormal ECGs during the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
Were any repeat vital signs recorded?
Beschreibung

Were any repeat vital signs recorded?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat Orthostatic Vital Signs recorded?
Beschreibung

Were any repeat Orthostatic Vital Signs recorded?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1827287
UMLS CUI [1,2]
C0205341
Were any repeat PK taken?
Beschreibung

Were any repeat PK taken?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0205341
Adverse Events
Beschreibung

Adverse Events

Alias
UMLS CUI-1
C0877248
Adverse Events Sequence Number
Beschreibung

Adverse Events Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348184
Adverse Event
Beschreibung

Diagnosis (if known), otherwise sign/symptom.

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Adverse Event Modified Term
Beschreibung

Adverse Event Modified Term

Datentyp

text

Alias
UMLS CUI [1]
C2826798
Adverse Event MedDRA synonym
Beschreibung

Adverse Event MedDRA synonym

Datentyp

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C1140263
Adverse Event MedDRA lower level term code
Beschreibung

Adverse Event MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C3898442
Adverse Event Failed coding
Beschreibung

Adverse Event Failed coding

Datentyp

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C0231175
Adverse Event Start Date and Time
Beschreibung

Adverse Event Start Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826806
Adverse Event Outcome
Beschreibung

Adverse Event Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Adverse Event End Date and Time
Beschreibung

Adverse Event End Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Adverse Event Frequency
Beschreibung

Adverse Event Frequency

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0439603
Adverse Event Maximum Intensity
Beschreibung

Adverse Event Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

Action Taken with Investigational Product(s) as a Result of the AE

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0877248
Did the subject withdraw from study as a result of this AE?
Beschreibung

Did the subject withdraw from study as a result of this AE?

Datentyp

boolean

Alias
UMLS CUI [1]
C1710677
UMLS CUI [2]
C0877248
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0439849
Does this Adverse Event meet the definition of serious?
Beschreibung

If "Yes", complete paper SAE form.

Datentyp

boolean

Alias
UMLS CUI [1]
C1710056
If Adverse Event is serious, chack all that apply
Beschreibung

If Adverse Event is serious, chack all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Specify other reason for serious Adverse Event
Beschreibung

Specify other reason for serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3840932
UMLS CUI [2]
C2348235
Was this SAE caused by an activity related to study participation (e.g., procedures)?
Beschreibung

Was this SAE caused by an activity related to study participation (e.g., procedures)?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [2]
C0441655
UMLS CUI [3]
C2348568
Serious Flag
Beschreibung

Serious Flag

Datentyp

text

Alias
UMLS CUI [1,1]
C0205404
UMLS CUI [1,2]
C1708067
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Concomitant Medications Sequence Number
Beschreibung

Concomitant Medications Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Concomitant Medications Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Concomitant Medications Modified reported term
Beschreibung

Concomitant Medications Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Concomitant Medications GSK Drug synonym
Beschreibung

Concomitant Medications GSK Drug synonym

Datentyp

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0871468
Concomitant Medications GSK Drug Collection Date
Beschreibung

Concomitant Medications GSK Drug Collection Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1516698
UMLS CUI [2]
C0011008
Concomitant Medications Failed coding
Beschreibung

Concomitant Medications Failed coding

Datentyp

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C0231175
Concomitant Medications Unit Dose
Beschreibung

Concomitant Medications Unit Dose

Datentyp

text

Alias
UMLS CUI [1]
C2826646
Concomitant Medications Units
Beschreibung

Concomitant Medications Units

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Concomitant Medications Frequency
Beschreibung

Concomitant Medications Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
UMLS CUI [2]
C2347852
Concomitant Medicaton Routes
Beschreibung

Concomitant Medicaton Routes

Datentyp

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0013153
Concomitant Medications Reason for Medication
Beschreibung

Concomitant Medications Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Concomitant Medications Start Date and Time
Beschreibung

Concomitant Medications Start Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826825
Concomitant Medications Taken Prior to Study?
Beschreibung

Concomitant Medication Taken Prior to Study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Concomitant Medications Ongoing?
Beschreibung

Concomitant Medications Ongoing?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
If Concomitant Medications not Ongoing, specify End Date and Time
Beschreibung

If Concomitant Medications not Ongoing, specify End Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826815
12-Lead/ Holter/ Telemetry ECG
Beschreibung

12-Lead/ Holter/ Telemetry ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-3
C0013801
UMLS CUI-5
C1623258
UMLS CUI-6
C0039451
Date and Time of ECG
Beschreibung

Date and Time of ECG

Datentyp

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Beschreibung

QTc Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG Abnormalities
Beschreibung

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
Date and Time of ECG
Beschreibung

Date and Time of ECG

Datentyp

datetime

Alias
UMLS CUI [1]
C2826846
A. Rhythm
Beschreibung

Record clinically significant abnormalities. Check all that apply.

Datentyp

text

Alias
UMLS CUI [1]
C0232187
Other abnormal rhythm
Beschreibung

Other abnormal rhythm

Datentyp

text

Alias
UMLS CUI [1,1]
C0199556
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0205394
B. P-Wave Morphology
Beschreibung

B. P-Wave Morphology

Datentyp

integer

Alias
UMLS CUI [1]
C2216025
Other morphology
Beschreibung

Other morphology

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0332437
C: Conduction
Beschreibung

C: Conduction

Datentyp

text

Alias
UMLS CUI [1]
C0232217
Other conduction
Beschreibung

Other conduction

Datentyp

text

Alias
UMLS CUI [1,1]
C0232217
UMLS CUI [1,2]
C0205394
D. Myocardial Infarction
Beschreibung

D. Myocardial Infarction

Datentyp

integer

Alias
UMLS CUI [1]
C0027051
Other myocardial infarction
Beschreibung

Other myocardial infarction

Datentyp

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
E. Depolarisation/Repolarisation (QRS-T)
Beschreibung

E. Depolarisation/Repolarisation (QRS-T)

Datentyp

integer

Alias
UMLS CUI [1]
C1395184
UMLS CUI [2]
C0948857
Other depolarisation/ repolarisation
Beschreibung

Other depolarisation/ repolarisation

Datentyp

text

Alias
UMLS CUI [1,1]
C2746082
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0948857
UMLS CUI [2,2]
C0205394
Other abnormalities, enter comment
Beschreibung

Other abnormalities, enter comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0205394
UMLS CUI [3]
C0947611
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/ time (Vital Signs)
Beschreibung

Actual date/ time (Vital Signs)

Datentyp

datetime

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C1264639
Subject position (Vital Signs)
Beschreibung

Subject position (Vital Signs)

Datentyp

integer

Alias
UMLS CUI [1]
C1262869
UMLS CUI [2]
C0518766
Systolic blood pressure (Vital Signs)
Beschreibung

Systolic blood pressure (Vital Signs)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0871470
mm[Hg]
Diastolic blood pressure (Vital Signs)
Beschreibung

Diastolic blood pressure (Vital Signs)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0428883
mm[Hg]
Blood pressure not done (Vital Signs)
Beschreibung

Blood pressure not done (Vital Signs)

Datentyp

integer

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0005823
UMLS CUI [3]
C1272696
Heart rate (Vital Signs)
Beschreibung

Heart rate (Vital Signs)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0018810
beats/min
Heart rate not done (Vital Signs)
Beschreibung

Heart rate not done (Vital Signs)

Datentyp

integer

Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0518766
UMLS CUI [3]
C1272696
Pharmacokinetics
Beschreibung

Pharmacokinetics

Alias
UMLS CUI-1
C0031328
Actual date/time (Pharmacokinetics)
Beschreibung

Actual date/time (Pharmacokinetics)

Datentyp

datetime

Alias
UMLS CUI [1]
C0031328
UMLS CUI [2]
C1264639
Orthostatic Vital Signs
Beschreibung

Orthostatic Vital Signs

Alias
UMLS CUI-1
C1827287
Actual date/time (Orthostatic Vital Signs)
Beschreibung

Actual date/time (Orthostatic Vital Signs)

Datentyp

datetime

Alias
UMLS CUI [1]
C1827287
UMLS CUI [2]
C1264639
Subject position (Orthostatic Vital Signs)
Beschreibung

Subject position (Orthostatic Vital Signs)

Datentyp

integer

Alias
UMLS CUI [1]
C1827287
UMLS CUI [2]
C1262869
Systolic blood pressure (Orthostatic Vital Signs)
Beschreibung

Systolic blood pressure (Orthostatic Vital Signs)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C1827287
UMLS CUI [2]
C0871470
mm[Hg]
Diastolic blood pressure (Orthostatic Vital Signs)
Beschreibung

Diastolic blood pressure (Orthostatic Vital Signs)

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C1827287
UMLS CUI [2]
C0428883
mm[Hg]
Blood pressure not done (Orthostatic Vital Signs)
Beschreibung

Blood pressure not done (Orthostatic Vital Signs)

Datentyp

integer

Alias
UMLS CUI [1]
C1827287
UMLS CUI [2]
C0005823
UMLS CUI [3]
C1272696
Heart rate (Orthostatic Vital Signs)
Beschreibung

Heart rate (Orthostatic Vital Signs)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C1827287
UMLS CUI [2]
C0018810
beats/min
Heart rate not done (Orthostatic Vital Signs)
Beschreibung

Heart rate not done (Orthostatic Vital Signs)

Datentyp

integer

Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C1827287
UMLS CUI [3]
C1272696
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Ähnliche Modelle

Logs and Repeats: Adverse Events; Concomitant Medications; ECG; Vital Signs; Pharmacokinetics

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Adverse Event/ Concomitant Medication/Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
C0205341 (UMLS CUI-5)
C0220825 (UMLS CUI-6)
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])
Did the subject experience any adverse events during the study?
Item
Did the subject experience any adverse events during the study?
boolean
C0877248 (UMLS CUI [1])
Were any repeat ECGs performed?
Item
Were any repeat ECGs performed?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Did the subject have any abnormal ECGs during the study?
Item
Did the subject have any abnormal ECGs during the study?
boolean
C0522055 (UMLS CUI [1])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat Orthostatic Vital Signs recorded?
Item
Were any repeat Orthostatic Vital Signs recorded?
boolean
C1827287 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat PK taken?
Item
Were any repeat PK taken?
boolean
C0031327 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Adverse Events Sequence Number
Item
Adverse Events Sequence Number
integer
C0877248 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Adverse Event Modified Term
Item
Adverse Event Modified Term
text
C2826798 (UMLS CUI [1])
Adverse Event MedDRA synonym
Item
Adverse Event MedDRA synonym
text
C0877248 (UMLS CUI [1])
C1140263 (UMLS CUI [2])
Adverse Event MedDRA lower level term code
Item
Adverse Event MedDRA lower level term code
text
C0877248 (UMLS CUI [1])
C3898442 (UMLS CUI [2])
Adverse Event Failed coding
Item
Adverse Event Failed coding
text
C0877248 (UMLS CUI [1])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Adverse Event Start Date and Time
Item
Adverse Event Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Adverse Event Outcome
integer
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Adverse Event Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/ Resolved with sequelae, provide End Date and Time (4)
CL Item
Fatal, record Date and Time of Death (5)
Adverse Event End Date and Time
Item
Adverse Event End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Adverse Event Frequency
integer
C0877248 (UMLS CUI [1])
C0439603 (UMLS CUI [2])
Adverse Event Frequency
Code List
Adverse Event Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Adverse Event Maximum Intensity
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Adverse Event Maximum Intensity
Code List
Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (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])
Action Taken with Investigational Product(s) as a Result of the AE
Code List
Action Taken with Investigational Product(s) as a Result of the 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 (6)
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])
C0877248 (UMLS CUI [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
C0877248 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0439849 (UMLS CUI [3])
Does this Adverse Event meet the definition of serious?
Item
Does this Adverse Event meet the definition of serious?
boolean
C1710056 (UMLS CUI [1])
Item
If Adverse Event is serious, chack all that apply
integer
C1519255 (UMLS CUI [1])
If Adverse Event is serious, chack all that apply
Code List
If Adverse Event is serious, chack all that apply
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/ incapacity (4)
CL Item
Congenital anomaly/ birth defect (5)
CL Item
Other, specify (6)
Specify other reason for serious Adverse Event
Item
Specify other reason for serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Was this SAE caused by an activity related to study participation (e.g., procedures)?
Item
Was this SAE caused by an activity related to study participation (e.g., procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
Serious Flag
Item
Serious Flag
text
C0205404 (UMLS CUI [1,1])
C1708067 (UMLS CUI [1,2])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medications Sequence Number
Item
Concomitant Medications Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Medications Drug Name
Item
Concomitant Medications Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medications Modified reported term
Item
Concomitant Medications Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Medications GSK Drug synonym
Item
Concomitant Medications GSK Drug synonym
text
C2347852 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0871468 (UMLS CUI [2,2])
Concomitant Medications GSK Drug Collection Date
Item
Concomitant Medications GSK Drug Collection Date
date
C2347852 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Concomitant Medications Failed coding
Item
Concomitant Medications Failed coding
text
C2347852 (UMLS CUI [1])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Concomitant Medications Unit Dose
Item
Concomitant Medications Unit Dose
text
C2826646 (UMLS CUI [1])
Concomitant Medications Units
Item
Concomitant Medications Units
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Concomitant Medications Frequency
Item
Concomitant Medications Frequency
text
C3476109 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Concomitant Medicaton Routes
Item
Concomitant Medicaton Routes
text
C2347852 (UMLS CUI [1])
C0013153 (UMLS CUI [2])
Concomitant Medications Reason for Medication
Item
Concomitant Medications Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Concomitant Medications Start Date and Time
Item
Concomitant Medications Start Date and Time
datetime
C2826825 (UMLS CUI [1])
Concomitant Medication Taken Prior to Study?
Item
Concomitant Medications Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medications Ongoing?
Item
Concomitant Medications Ongoing?
boolean
C2826666 (UMLS CUI [1])
If Concomitant Medications not Ongoing, specify End Date and Time
Item
If Concomitant Medications not Ongoing, specify End Date and Time
datetime
C2826815 (UMLS CUI [1])
Item Group
12-Lead/ Holter/ Telemetry ECG
C0430456 (UMLS CUI-1)
C0013801 (UMLS CUI-3)
C1623258 (UMLS CUI-5)
C0039451 (UMLS CUI-6)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
CL Item
No result (4)
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Item
A. Rhythm
text
C0232187 (UMLS CUI [1])
A. Rhythm
Code List
A. Rhythm
CL Item
Sinus bradycardia (1)
CL Item
Sinus bradycardia (heart rate 40 - 50 betas/min) (2)
CL Item
Sinus bradycarida (heart rate 30 - 39 beats/min) (3)
CL Item
Sinus bradycarida (heart rate <30 beats/min) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Ectopic supraventricular rhythm (8)
CL Item
Wandering atrial pacemaker (9)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (10)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (11)
CL Item
Atrial flutter (12)
CL Item
Atrial fibrillation (13)
CL Item
100 beats/min) (Junctional rhythm (heart rate <)
CL Item
Junctional rhythm (15)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (16)
CL Item
Ectopic ventricular beats (17)
CL Item
Ventricular couplets (18)
CL Item
Bigeminy (19)
CL Item
Trigeminy (20)
CL Item
Electrical alternans (21)
CL Item
R on T phenomenon (22)
CL Item
Ventricular fibrillation (23)
CL Item
Idioventricular rhythm (24)
CL Item
Sustained ventriculat tachycardia (25)
CL Item
Non-sustained ventricular tachycardia (26)
CL Item
Ventricular tachycardia (27)
CL Item
Monomorphic ventricular tachycardia (28)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (29)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (30)
CL Item
Artificial Pacemaker (31)
CL Item
Other abnormal rhythm, enter comment (32)
Other abnormal rhythm
Item
Other abnormal rhythm
text
C0199556 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Item
B. P-Wave Morphology
integer
C2216025 (UMLS CUI [1])
B. P-Wave Morphology
Code List
B. P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraartrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology, enter comment (6)
Other morphology
Item
Other morphology
text
C0205394 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
Item
C: Conduction
text
C0232217 (UMLS CUI [1])
C: Conduction
Code List
C: Conduction
CL Item
First degree AV block (PR interval >200msec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (6)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Incomplete left bundle branch block (9)
CL Item
Right bundle branch block (10)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (11)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (12)
CL Item
Left bundle branch block (13)
CL Item
Bifascicular block (14)
CL Item
120msec) (Non-specific intraventricular conduction delay (QRS >)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Gagnon-Levine) (16)
CL Item
500msec (QT/QTc prolongation >)
CL Item
AV dissociation (18)
CL Item
Other conduction, enter comment (19)
Other conduction
Item
Other conduction
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
D. Myocardial Infarction
integer
C0027051 (UMLS CUI [1])
D. Myocardial Infarction
Code List
D. Myocardial Infarction
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, Non Q-wave (7)
CL Item
Other Myocardial infarction, enter comment (8)
Other myocardial infarction
Item
Other myocardial infarction
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
E. Depolarisation/Repolarisation (QRS-T)
integer
C1395184 (UMLS CUI [1])
C0948857 (UMLS CUI [2])
E. Depolarisation/Repolarisation (QRS-T)
Code List
E. Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST-elevation-pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/ inversion (13)
CL Item
Other depolarisation/ repolarisation, enter comment (14)
Other depolarisation/ repolarisation
Item
Other depolarisation/ repolarisation
text
C2746082 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Other abnormalities, enter comment
Item
Other abnormalities, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date/ time (Vital Signs)
Item
Actual date/ time (Vital Signs)
datetime
C0518766 (UMLS CUI [1])
C1264639 (UMLS CUI [2])
Item
Subject position (Vital Signs)
integer
C1262869 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
Subject position (Vital Signs)
Code List
Subject position (Vital Signs)
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
Systolic blood pressure (Vital Signs)
Item
Systolic blood pressure (Vital Signs)
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Diastolic blood pressure (Vital Signs)
Item
Diastolic blood pressure (Vital Signs)
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Item
Blood pressure not done (Vital Signs)
integer
C0518766 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
Blood pressure not done (Vital Signs)
Code List
Blood pressure not done (Vital Signs)
CL Item
Not Done (1)
Heart rate (Vital Signs)
Item
Heart rate (Vital Signs)
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
Item
Heart rate not done (Vital Signs)
integer
C0018810 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
Heart rate not done (Vital Signs)
Code List
Heart rate not done (Vital Signs)
CL Item
Not Done (1)
Item Group
Pharmacokinetics
C0031328 (UMLS CUI-1)
Actual date/time (Pharmacokinetics)
Item
Actual date/time (Pharmacokinetics)
datetime
C0031328 (UMLS CUI [1])
C1264639 (UMLS CUI [2])
Item Group
Orthostatic Vital Signs
C1827287 (UMLS CUI-1)
Actual date/time (Orthostatic Vital Signs)
Item
Actual date/time (Orthostatic Vital Signs)
datetime
C1827287 (UMLS CUI [1])
C1264639 (UMLS CUI [2])
Item
Subject position (Orthostatic Vital Signs)
integer
C1827287 (UMLS CUI [1])
C1262869 (UMLS CUI [2])
Subject position (Orthostatic Vital Signs)
Code List
Subject position (Orthostatic Vital Signs)
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
Systolic blood pressure (Orthostatic Vital Signs)
Item
Systolic blood pressure (Orthostatic Vital Signs)
integer
C1827287 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Diastolic blood pressure (Orthostatic Vital Signs)
Item
Diastolic blood pressure (Orthostatic Vital Signs)
integer
C1827287 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Item
Blood pressure not done (Orthostatic Vital Signs)
integer
C1827287 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
Blood pressure not done (Orthostatic Vital Signs)
Code List
Blood pressure not done (Orthostatic Vital Signs)
CL Item
Not Done (1)
Heart rate (Orthostatic Vital Signs)
Item
Heart rate (Orthostatic Vital Signs)
integer
C1827287 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
Item
Heart rate not done (Orthostatic Vital Signs)
integer
C0018810 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
Heart rate not done (Orthostatic Vital Signs)
Code List
Heart rate not done (Orthostatic Vital Signs)
CL Item
Not Done (1)
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