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ID
32143
Beschreibung
Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma
Stichworte
Versionen (1)
- 21.10.18 21.10.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
21. Oktober 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125
Electronically Transverred Lab Data, Vital Signs, ECG, Investigational Product, Pharmacodynamics Blood, Cortisol and Results -Period 2; Day 11 - 13
Ähnliche Modelle
Electronically Transverred Lab Data, Vital Signs, ECG, Investigational Product, Pharmacodynamics Blood, Cortisol and Results -Period 2; Day 11 - 13
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Electronically transferred lab data - Day 10
C0022885 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
C1320722 (UMLS CUI-2)
Hematology Date and time sample taken
Item
Hematology Date and time sample taken
datetime
C0018943 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Dosing date and time - Vital signs
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Dosing date and time
Item
Dosing date and time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Blood Pressure and Heart rate - Pre Dose
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 15 M
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
float
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 30 M
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 45 M
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 1 H
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 1.5 H
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 2 H
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 3 H
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 4 H
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 5 H
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 6 H
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate - 8 H
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate -12 H
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Blood Pressure and Heart rate -24 H
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Dosing date and time - ECG
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Dosing date and time
Item
Dosing date and time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
float
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanically, check method of calculation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
Code List
If QTc interval was calculated mechanically, check method of calculation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTc interval finding Bazett's formula
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,2])
QTc interval finding Fridericia's formula
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
QTc interval finding with RR interval
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Investigational Product (Dose) - Day 11
C0304229 (UMLS CUI-1)
C3174092 (UMLS CUI-2)
C3174092 (UMLS CUI-2)
Ketoconazole Start date/ time of dose
Item
Ketoconazole - Start date/ time of dose
datetime
C0022625 (UMLS CUI [1,1])
C2983667 (UMLS CUI [1,2])
C2983667 (UMLS CUI [1,2])
Ketoconazole - Correct treatment during dosage interval
Item
Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
Reasons for wrong treatment
Item
Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
text
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
FF/GW642444M Start date/ time of dose
Item
FF/GW642444M - Start date/ time of dose
datetime
C0304229 (UMLS CUI [1,1])
C2983667 (UMLS CUI [1,2])
C2983667 (UMLS CUI [1,2])
FF/GW642444M - Correct treatment during dosage interval
Item
FF/GW642444M - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0304229 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
FF/GW642444M - Reasons for wrong treatment
Item
FF/GW642444M - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
text
C0304229 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Item Group
Pharmacokinetics Blood - FF/GW642444M
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0005767 (UMLS CUI-2)
Dosing date/ time
Item
Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pre Dose - Actual time
Item
Pre Dose - Actual time
time
C0439565 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
5 M - Actual time
Item
5 M - Actual time
time
C0040223 (UMLS CUI [1])
15 M - Actual time
Item
15 M - Actual time
time
C0040223 (UMLS CUI [1])
30 M - Actual time
Item
30 M - Actual time
time
C0040223 (UMLS CUI [1])
45 M - Actual time
Item
45 M - Actual time
time
C0040223 (UMLS CUI [1])
1 H - Actual time
Item
1 H - Actual time
time
C0040223 (UMLS CUI [1])
1.5 H - Actual time
Item
1.5 H - Actual time
time
C0040223 (UMLS CUI [1])
2 H - Actual time
Item
2 H - Actual time
time
C0040223 (UMLS CUI [1])
3 H - Actual time
Item
3 H - Actual time
time
C0040223 (UMLS CUI [1])
4 H - Actual time
Item
4 H - Actual time
time
C0040223 (UMLS CUI [1])
5 H - Actual time
Item
5 H - Actual time
time
C0040223 (UMLS CUI [1])
6 H - Actual time
Item
6 H - Actual time
time
C0040223 (UMLS CUI [1])
8 H - Actual time
Item
8 H - Actual time
time
C0040223 (UMLS CUI [1])
10 H - Actual time
Item
10 H - Actual time
time
C0040223 (UMLS CUI [1])
12 H - Actual date and time
Item
12 H - Actual date and time
datetime
C1264639 (UMLS CUI [1])
24 H - Actual date and time
Item
24 H - Actual date and time
datetime
C1264639 (UMLS CUI [1])
36 H - Actual date and time
Item
36 H - Actual date and time
datetime
C1264639 (UMLS CUI [1])
48 H - Actual date and time
Item
48 H - Actual date and time
datetime
C1264639 (UMLS CUI [1])
Item Group
Pharmacodynamics - Cortisol
C0851347 (UMLS CUI-1)
C0020268 (UMLS CUI-2)
C0020268 (UMLS CUI-2)
Dosing date/ time
Item
Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - Pre Dose
Item
Date/ time of sample - Pre Dose
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - 1 H
Item
Date/ time of sample - 1 H
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - 2 H
Item
Date/ time of sample - 2 H
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - 3 H
Item
Date/ time of sample - 3 H
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - 4 H
Item
Date/ time of sample - 4 H
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - 6 H
Item
Date/ time of sample - 6 H
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - 8 H
Item
Date/ time of sample - 8 H
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - 10 H
Item
Date/ time of sample - 10 H
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - 12 H
Item
Date/ time of sample - 12 H
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - 16 H
Item
Date/ time of sample - 16 H
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Date/ time of sample - 24 H
Item
Date/ time of sample - 24 H
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Item Group
Dosing date and time - Pharmacodynamics Results - Potassium
C0851347 (UMLS CUI-1)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C1264639 (UMLS CUI-5)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C1264639 (UMLS CUI-5)
Dosing date/ time
Item
Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Pharmacodynamics Results - Potassium - Pre Dose
C0851347 (UMLS CUI-1)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Text result (2)
Analyte numeric result
Item
Analyte numeric result
float
C0443354 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,2])
Analyte Text result
Item
Analyte Text result
text
C0443354 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
Item Group
Pharmacodynamics Results - Potassium - 30 M
C0851347 (UMLS CUI-1)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Text result (2)
Analyte numeric result
Item
Analyte numeric result
float
C0443354 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,2])
Analyte Text result
Item
Analyte Text result
text
C0443354 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
Item Group
Pharmacodynamics Results - Potassium - 1 H
C0851347 (UMLS CUI-1)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Text result (2)
Analyte numeric result
Item
Analyte numeric result
float
C0443354 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,2])
Analyte Text result
Item
Analyte Text result
text
C0443354 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
Item Group
Pharmacodynamics Results - Potassium - 2 H
C0851347 (UMLS CUI-1)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Text result (2)
Analyte numeric result
Item
Analyte numeric result
float
C0443354 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,2])
Analyte Text result
Item
Analyte Text result
text
C0443354 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
Item Group
Pharmacodynamics Results - Potassium - 4 H
C0851347 (UMLS CUI-1)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0032821 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
Time of sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
CL Item
Numeric result (1)
CL Item
Text result (2)
Analyte numeric result
Item
Analyte numeric result
float
C0443354 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,2])
Analyte Text result
Item
Analyte Text result
text
C0443354 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C1527021 (UMLS CUI [1,3])
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