Informazione:
Errore:
ID
37667
Descrizione
Study ID: 105377 Clinical Study ID: 105377 Study Title: A randomised, open-label, parallel-group design study to evaluate the pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Epilepsy
Keywords
versioni (4)
- 12/08/19 12/08/19 -
- 14/08/19 14/08/19 -
- 14/08/19 14/08/19 -
- 14/08/19 14/08/19 -
Titolare del copyright
GlaxoSmithKline
Caricato su
14 agosto 2019
DOI
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Licenza
Creative Commons BY-NC 3.0
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Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377)
Screen - 12-Lead/ Holter/ Telemetry ECG; 21-Lead ECG Abnormalities
Similar models
Screen - 12-Lead/ Holter/ Telemetry ECG; 21-Lead ECG Abnormalities
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Item Group
12-Lead/ Holter/ Telemetry ECG
C0430456 (UMLS CUI-1)
C0013801 (UMLS CUI-2)
C1623258 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
C0013801 (UMLS CUI-2)
C1623258 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
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 lnterval
Item
PR lnterval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT lnterval
Item
Uncorrected QT lnterval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (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 (1)
CL Item
Manual (2)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significan (2)
CL Item
Abnormal, clinically significant (complete the AE form if clinically rignificant abnormalities meet the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 3(}-39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate> 100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal atrial tachycardia (wandering attial pacemaker w/rate > 100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate> 100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate <=I00 beats/min) (A5)
CL Item
Junctional rhythm (A25)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Trigeminy (A28)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
ldioventricular rhythm (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic venlricular tachycardia (A30)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial Pacemaker (A16)
CL Item
Other abnormal rhythm, enter comment (A99)
A. If other abnormal rhythm, enter comment
Item
A. If other abnormal rhythm, enter comment
text
C0232187 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology, enter comment (B99)
B. If other morphology, enter comment
Item
B. If other morphology, enter comment
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])
CL Item
First degree AV block (PR interval > 200msec) (C1)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (C5)
CL Item
Right axis deviation (QRS axis more positive than + 110 degrees) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120 msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
QT/QTc prolongation >= 500 msec (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction, enter comment (C99)
C. If other conduction, enter comment
Item
C. If other conduction, enter comment
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
CL Item
Myocardial infarction, old (D1)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, lateral (D3)
CL Item
Myocardial infarction, posterior (D4)
CL Item
Myocardial infarction, inferior (D5)
CL Item
Myocardial infarction, septal (D6)
CL Item
Myocardial infarction, Non Q-wave (D20)
CL Item
Other myocardial infarction, enter comment (D98)
D. If other myocardial infarction, enter comment
Item
D. If other myocardial infarction, enter comment
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
E. Depolarisation/Repolarisation (QRS-T)
text
C1395184 (UMLS CUI [1])
C0948857 (UMLS CUI [2])
C0948857 (UMLS CUI [2])
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST-elevation - pericarditis (D21)
CL Item
ST depression (D9)
CL Item
U waves abnormal (D10)
CL Item
T wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattering/ inversion (D17)
CL Item
Other depolarisation/ repolarisation, enter comment (D99)
E. If other depolarisation/ repolarisation, enter comment
Item
E. If other depolarisation/ repolarisation, enter comment
text
C1395184 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
If other abnormalities, enter comment
Item
If other abnormalities, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item Group
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
C1705822 (UMLS CUI-2)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sample not taken
integer
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Not done (1)
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])
C1264639 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Clinical Chemistry sample not taken
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Not done (1)
Item
Clinical Chemistry same as the Haematology sample
integer
C0200345 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2])
Code List
Clinical Chemistry same as the Haematology sample
CL Item
Same as the Haematology sample (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinalysis sample not taken.
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Not done (1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])