Informações:
Falhas:
ID
40272
Descrição
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the data entry for the electrocardiogram abnormalities. It has to be filled in for Screening, Visit day-1, week 1-3 and the follow-up visit if results of ECG show clinically significant abnormalities. Repeat measurements as often as necessary in logs and repeats.
Link
https://clinicaltrials.gov/ct2/show/NCT00821054
Palavras-chave
Versões (2)
- 26/03/2020 26/03/2020 - Christian Arras
- 26/03/2020 26/03/2020 - Christian Arras
Titular dos direitos
GlaxoSmithKline
Transferido a
26 de março de 2020
DOI
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Licença
Creative Commons BY-NC 4.0
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Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054
Similar models
ECG abnormalities
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Date of Visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
CL Item
Screen (Screen)
CL Item
Day-1 (Day-1)
CL Item
Week 1 (Week 1)
CL Item
Week2 (Week 2)
CL Item
Week 3 (Week 3)
CL Item
F/U (F/U)
CL Item
Logs/Repeats (Logs/Rpts)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Sinus bradycardia
Item
Sinus bradycardia
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (heart rate 40-50 beats/min)
Item
Sinus bradycardia (heart rate 40-50 beats/min)
boolean
C0085610 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus bradycardia (heart rate 30-39 beats/min)
Item
Sinus bradycardia (heart rate 30-39 beats/min)
boolean
C0085610 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus bradycardia (heart rate <30 beats/min)
Item
Sinus bradycardia (heart rate <30 beats/min)
boolean
C0085610 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Sinus tachycardia
Item
Sinus tachycardia (heart rate> 100 beats/min)
boolean
C0039239 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Ectopic supraventricular rhythm
Item
Ectopic supraventricular rhythm
boolean
C2348376 (UMLS CUI [1])
Wandering atrial pacemaker
Item
Wandering atrial pacemaker
boolean
C1321523 (UMLS CUI [1])
Multifocal atrial tachycardia
Item
Multifocal atrial tachycardia (wandering atrial pacemaker with heart rate > 100 beats/min)
boolean
C0221158 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Supraventricular tachycardia
Item
Supraventricular tachycardia (heart rate > 100 beats/min)
boolean
C0039240 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial fibrillation
Item
Atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Junctional rhythm (heart rate <= 100 beats/min)
Item
Junctional rhythm (heart rate <= 100 beats/min)
boolean
C0232208 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Junctional rhythm
Item
Junctional rhythm
boolean
C0232208 (UMLS CUI [1])
Junctional tachycardia
Item
Junctional tachycardia (heart rate > 100 beats/min)
boolean
C0039235 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
Ectopic ventricular beats
Item
Ectopic ventricular beats
boolean
C0151636 (UMLS CUI [1])
Ventricular couplets
Item
Ventricular couplets
boolean
C0429001 (UMLS CUI [1])
Bigeminy
Item
Bigeminy
boolean
C0262662 (UMLS CUI [1])
Trigeminy
Item
Trigeminy
boolean
C0428999 (UMLS CUI [1])
Electrical alternans
Item
Electrical alternans
boolean
C1142551 (UMLS CUI [1])
R on T phenomenon
Item
R on T phenomenon
boolean
C0877658 (UMLS CUI [1])
Ventricular fibrillation
Item
Ventricular fibrillation
boolean
C0042510 (UMLS CUI [1])
ldioventricular rhythm
Item
ldioventricular rhythm
boolean
C0700363 (UMLS CUI [1])
Sustained ventricular tachycardia
Item
Sustained ventricular tachycardia
boolean
C0750197 (UMLS CUI [1])
Non-sustained ventricular tachycardia
Item
Non-sustained ventricular tachycardia
boolean
C0750194 (UMLS CUI [1])
Wide QRS tachycardia
Item
Wide QRS tachycardia (diagnosis unknown)
boolean
C0344429 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Ventricular tachycardia
Item
Ventricular tachycardia
boolean
C0042514 (UMLS CUI [1])
Monomorphic ventricular tachycardia
Item
Monomorphic ventricular tachycardia
boolean
C0344431 (UMLS CUI [1])
Torsades de Pointes
Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
boolean
C0040479 (UMLS CUI [1])
Polymorphic ventricular tachycardia
Item
Polymorphic (sustained and non-sustained) ventricular tachycardia
boolean
C0344432 (UMLS CUI [1,1])
C0750197 (UMLS CUI [1,2])
C0344432 (UMLS CUI [2,1])
C0750194 (UMLS CUI [2,2])
C0750197 (UMLS CUI [1,2])
C0344432 (UMLS CUI [2,1])
C0750194 (UMLS CUI [2,2])
Artificial Pacemaker
Item
Artificial Pacemaker
boolean
C0030163 (UMLS CUI [1])
Other abnormal rhythm
Item
Other abnormal rhythm
boolean
C0205394 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Comment abnormal rhythm
Item
If other abnormal rhythm, please specify
text
C0947611 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Left atrial abnormality (P mitrale)
Item
Left atrial abnormality (P mitrale)
boolean
C0344711 (UMLS CUI [1,1])
C0232310 (UMLS CUI [1,2])
C0232310 (UMLS CUI [1,2])
Right atrial abnormality (P pulmonale)
Item
Right atrial abnormality (P pulmonale)
boolean
C0344696 (UMLS CUI [1,1])
C0232308 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
Right ventricular hypertrophy
Item
Right ventricular hypertrophy
boolean
C0162770 (UMLS CUI [1])
Intraatrial conduction delay
Item
Intraatrial conduction delay
boolean
C2346510 (UMLS CUI [1])
Increased voltage consistent with left ventricular hypertrophy
Item
Increased voltage consistent with left ventricular hypertrophy
boolean
C1112650 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0149721 (UMLS CUI [1,3])
C0332290 (UMLS CUI [1,2])
C0149721 (UMLS CUI [1,3])
Other morphology
Item
Other morphology
boolean
C0205394 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
Comment other morphology
Item
If other morphology, please specify
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
First degree AV block
Item
First degree AV block (PR interval> 200msec)
boolean
C0085614 (UMLS CUI [1])
Short PR interval
Item
Short PR interval
boolean
C0520878 (UMLS CUI [1])
Second degree AV block (Mobitz type 1)
Item
Second degree AV block (Mobitz type 1)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
2: 1 AV block
Item
2: 1 AV block
boolean
C2346542 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation
Item
Left axis deviation (QRS axis more negative than -30 degrees)
boolean
C0232297 (UMLS CUI [1])
Right axis deviation
Item
Right axis deviation (QRS axis more positive than +110 degrees)
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Incomplete left bundle branch block
Item
Incomplete left bundle branch block
boolean
C0281878 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left anterior hemiblock
Item
Left anterior hemiblock
boolean
C0264912 (UMLS CUI [1])
Left posterior hemiblock
Item
Left posterior hemiblock
boolean
C0264913 (UMLS CUI [1])
Left bundle branch block
Item
Left bundle branch block
boolean
C0023211 (UMLS CUI [1])
Bifascicular block
Item
Bifascicular block
boolean
C0264914 (UMLS CUI [1])
Non-specific intraventricular conduction delay
Item
Non-specific intraventricular conduction delay (QRS >= 120 msec)
boolean
C3697597 (UMLS CUI [1])
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
C1963785 (UMLS CUI [1,1])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
Prolonged QT interval
Item
Prolonged QT interval
boolean
C0151878 (UMLS CUI [1])
QT/QTc prolongation by QTc time
Item
QT/QTc prolongation >=500msec
boolean
C0855333 (UMLS CUI [1])
C0489625 (UMLS CUI [2])
C0489625 (UMLS CUI [2])
AV dissociation
Item
AV dissociation
boolean
C0004331 (UMLS CUI [1])
Other conduction abnormality
Item
Other conduction abnormality
boolean
C0340494 (UMLS CUI [1])
Comment other conduction abnormality
Item
If other conduction abnormality, please specify
text
C0340494 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, anterior
Item
Myocardial infarction, anterior
boolean
C0340293 (UMLS CUI [1])
Myocardial infarction, lateral
Item
Myocardial infarction, lateral
boolean
C0340312 (UMLS CUI [1])
Myocardial infarction, posterior
Item
Myocardial infarction, posterior
boolean
C0340319 (UMLS CUI [1])
Myocardial infarction, inferior
Item
Myocardial infarction, inferior
boolean
C0340305 (UMLS CUI [1])
Myocardial infarction, septal
Item
Myocardial infarction, septal
boolean
C0746727 (UMLS CUI [1])
Myocardial infarction, Non Q-wave
Item
Myocardial infarction, Non Q-wave
boolean
C0542269 (UMLS CUI [1])
Other myocardial infarction
Item
Other myocardial infarction
boolean
C0205394 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])
Comment other myocardial infarction
Item
If other myocardial infarction, please specify
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Depolarisation/Repolarisation (QRS-T)
C0948857 (UMLS CUI-1)
C1331539 (UMLS CUI-2)
C1331539 (UMLS CUI-2)
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
J point elevation
Item
J point elevation
boolean
C2346597 (UMLS CUI [1])
ST elevation
Item
ST elevation
boolean
C0520886 (UMLS CUI [1])
ST-elevation - pericarditis
Item
ST-elevation - pericarditis
boolean
C2348119 (UMLS CUI [1])
ST depression
Item
ST depression
boolean
C0520887 (UMLS CUI [1])
ST segment abnormality, not specified
Item
ST segment abnormality, not specified
boolean
C2348120 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,2])
U waves abnormal
Item
U waves abnormal
boolean
C0438169 (UMLS CUI [1])
T wave inversion
Item
T wave inversion
boolean
C0520888 (UMLS CUI [1])
T wave peaked
Item
T wave peaked
boolean
C0239242 (UMLS CUI [1])
T waves flat
Item
T waves flat
boolean
C2215959 (UMLS CUI [1])
T waves biphasic
Item
T waves biphasic
boolean
C2348639 (UMLS CUI [1])
Notched T-waves
Item
Notched T-waves
boolean
C2347367 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
T-wave flattening/inversion
Item
T-wave flattening/inversion
boolean
C0520888 (UMLS CUI [1])
C0429059 (UMLS CUI [2])
C0429059 (UMLS CUI [2])
T-wave abnormality, not specified
Item
T-wave abnormality, not specified
boolean
C0438167 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,2])
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation
boolean
C0205394 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Comment other depolarisation/repolarisation
Item
If other depolarisation/repolarisation, please specify
text
C0205394 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
ECG, Other abnormalities
Item
Other abnormalities
boolean
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
If other abnormalities, please specify:
Item
If other abnormalities, please specify:
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])