ID

40272

Beschrijving

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

Trefwoorden

Gynecology

Klinische Studie [Dokumenttyp]

D017426

Electrocardiogram (ECG)

D001943

26-03-20 26-03-20 - Christian Arras
26-03-20 26-03-20 - Christian Arras

Houder van rechten

GlaxoSmithKline

Geüploaded op

26 maart 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

model
Details

ECG abnormalities

1 Formulieren

StudyEvent: ODM
1. ECG abnormalities

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Administrative Data

Item Group

Administrative Data

C1320722 (UMLS CUI-1)

Date of Visit

Item

Visit Date

date

C1320303 (UMLS CUI [1])

Subject number

Item

Subject number

integer

C2348585 (UMLS CUI [1])

Visit type

Item

Visit type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])

Visit type

Code List

Visit type

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)

12-Lead ECG Abnormalities

Item Group

ECG Abnormalities

C0522055 (UMLS CUI-1)

Date and Time of ECG

Item

Date and Time of ECG

datetime

C2826846 (UMLS CUI [1])

Rhythm

Item Group

Rhythm

C0232187 (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])

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])

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])

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])

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])

Supraventricular tachycardia

Item

Supraventricular tachycardia (heart rate > 100 beats/min)

boolean

C0039240 (UMLS CUI [1,1])
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])

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])

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])

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])

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])

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])

P-Wave Morphology

Item Group

P-Wave Morphology

C2216025 (UMLS CUI-1)

Left atrial abnormality (P mitrale)

Item

Left atrial abnormality (P mitrale)

boolean

C0344711 (UMLS CUI [1,1])
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])

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])

Other morphology

Item

Other morphology

boolean

C0205394 (UMLS CUI [1,1])
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])

Conduction

Item Group

Conduction

C0264886 (UMLS CUI-1)

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])

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])

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])

Myocardial Infarction

Item Group

Myocardial Infarction

C0027051 (UMLS CUI-1)

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])

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])

Depolarisation/Repolarisation (QRS-T)

Item Group

Depolarisation/Repolarisation (QRS-T)

C0948857 (UMLS CUI-1)
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])

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])

T-wave abnormality, not specified

Item

T-wave abnormality, not specified

boolean

C0438167 (UMLS CUI [1,1])
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])

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])

ECG, Other abnormalities

Item Group

Other abnormalities

C0522055 (UMLS CUI-1)
C0205394 (UMLS CUI-2)

ECG, Other abnormalities

Item

Other abnormalities

boolean

C0522055 (UMLS CUI [1,1])
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])

Terug naar het begin van de pagina

ID

Beschrijving

Link

Trefwoorden

Versies (2)

Houder van rechten

Geüploaded op

DOI

Licentie

Model Commentaren :

Itemgroep Commentaren voor :

Item Commentaren voor :

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

ECG abnormalities

Beschrijving

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Alias

Beschrijving

Datatype

Alias

Beschrijving

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias