ID

37668

Beschrijving

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

Trefwoorden

Versies (2)
  1. 14-08-19 14-08-19 -
  2. 14-08-19 14-08-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

14 augustus 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
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 :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

Geen commentaren

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

Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377)

Engels

Visit 1 - Randomisation Number; 12-Lead ECG; 12-Lead ECG Abnormalities; Vital Signs; Investigational Product; Treatment Confirmation; Electronically Transferred Lab Data; Pharmacokinetics Blood

1 Formulieren  
Date of Visit/ Assessment
Beschrijving

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Beschrijving

Date of Visit/ Assessment

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Randomisation
Beschrijving

Randomisation

Alias
UMLS CUI-1
C0034656
Was the subject able to be randomised?
Beschrijving

Was the subject able to be randomised?

Datatype

boolean

Alias
UMLS CUI [1]
C0034656
Randomisation Number
Beschrijving

Randomisation Number

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Beschrijving

Date of randomisation

Datatype

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
12-Lead ECG
Beschrijving

12-Lead ECG

Alias
UMLS CUI-1
C0430456
12-Lead ECG - Dosing Date and Time
Beschrijving

12-Lead ECG - Dosing Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0040223
Date and Time of ECG (Pre-dose)
Beschrijving

Date and Time of ECG (Pre-dose)

Datatype

datetime

Alias
UMLS CUI [1]
C2826846
UMLS CUI [2]
C0439565
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beschrijving

PR Interval

Datatype

integer

Maateenheden
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschrijving

QRS Duration

Datatype

integer

Maateenheden
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Beschrijving

Uncorrected QT Interval

Datatype

integer

Maateenheden
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Beschrijving

QTc Interval

Datatype

integer

Maateenheden
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Beschrijving

Method of QTc Calculation

Datatype

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Beschrijving

Result of the ECG

Datatype

integer

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

12-Lead ECG Abnormalities

Date and Time of ECG
Beschrijving

Date and Time of ECG

Datatype

datetime

Alias
UMLS CUI [1]
C2826846
A. Rhythm
Beschrijving

Record clinically significant abnormalities

Datatype

text

Alias
UMLS CUI [1]
C0232187
A. If other abnormal rhythm, enter comment
Beschrijving

A. If other abnormal rhythm, enter comment

Datatype

text

Alias
UMLS CUI [1,1]
C0232187
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0947611
B. P-Wave Morphology
Beschrijving

Record clinically significant abnormalities

Datatype

text

Alias
UMLS CUI [1]
C2216025
B. If other morphology, enter comment
Beschrijving

B. If other morphology, enter comment

Datatype

text

Alias
UMLS CUI [1,1]
C0332437
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
C. Conduction
Beschrijving

C. Conduction

Datatype

text

Alias
UMLS CUI [1]
C0232217
C. If other conduction, enter comment
Beschrijving

C. If other conduction, enter comment

Datatype

text

Alias
UMLS CUI [1,1]
C0232217
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
D. Myocardial Infarction
Beschrijving

D. Myocardial Infarction

Datatype

text

Alias
UMLS CUI [1]
C0027051
D. If other myocardial infarction, enter comment
Beschrijving

D. If other myocardial infarction, enter comment

Datatype

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
E. Depolarisation/Repolarisation (QRS-T)
Beschrijving

E. Depolarisation/Repolarisation (QRS-T)

Datatype

text

Alias
UMLS CUI [1]
C1395184
UMLS CUI [2]
C0948857
E. If other depolarisation/ repolarisation, enter comment
Beschrijving

E. If other depolarisation/ repolarisation, enter comment

Datatype

text

Alias
UMLS CUI [1,1]
C1395184
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
UMLS CUI [2,1]
C0948857
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0947611
If other abnormalities, enter comment
Beschrijving

If other abnormalities, enter comment

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0947611
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Dosing date/time
Beschrijving

Vital Signs - Dosing date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0518766
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0040223
Vital Signs - Actual date/time (Pre-dose)
Beschrijving

Vital Signs - Actual date/time (Pre-dose)

Datatype

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
UMLS CUI [2]
C0439565
Systolic Blood pressure
Beschrijving

Systolic Blood pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood pressure
Beschrijving

Diastolic Blood pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Vital Signs - Heart rate
Beschrijving

Vital Signs - Heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational product - Date/time of dose
Beschrijving

Investigational product - Date/time of dose

Datatype

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0040223
Treatment Confirmation
Beschrijving

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment ( e.g., treatment which the subject was assigned to) during this dosing interval?
Beschrijving

Did the subject receive the correct treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If subject did not receive the correct treatment, record reason
Beschrijving

If subject did not receive the correct treatment, record reason

Datatype

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0392360
Electronically Transferred Lab Data
Beschrijving

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Haematology Date and time sample taken
Beschrijving

Haematology Date and time sample taken

Datatype

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sample not taken
Beschrijving

Haematology sample not taken

Datatype

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Beschrijving

Clinical Chemistry Date and time sample taken

Datatype

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Clinical Chemistry sample not taken
Beschrijving

Clinical Chemistry sample not taken

Datatype

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Clinical Chemistry same as the Haematology sample
Beschrijving

Clinical Chemistry same as the Haematology sample

Datatype

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0008000
UMLS CUI [2]
C0018941
Urinalysis Date and time sample taken
Beschrijving

Urinalysis Date and time sample taken

Datatype

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis sample not taken.
Beschrijving

Urinalysis sample not taken.

Datatype

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
Beschrijving

Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0064636
UMLS CUI-4
C0178602
UMLS CUI-5
C0011008
UMLS CUI-6
C0040223
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
Beschrijving

Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0064636
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Pharmacokinetics Blood Pre-36h (Lamotrigine)
Beschrijving

Pharmacokinetics Blood Pre-36h (Lamotrigine)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0064636
UMLS CUI-4
C0178602
UMLS CUI-5
C0011008
UMLS CUI-6
C0040223
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint
Beschrijving

Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0064636
UMLS CUI [2]
C2348792
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Actual date/time
Beschrijving

Pharmacokinetics Blood Pre-36h (Lamotrigine) - Actual date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0064636
UMLS CUI [2]
C1264639
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
Beschrijving

Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0064636
UMLS CUI-4
C0178602
UMLS CUI-5
C0011008
UMLS CUI-6
C0040223
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
Beschrijving

Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0064636
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Pharmacokinetics Blood 48h - 144h (Lamotrigine)
Beschrijving

Pharmacokinetics Blood 48h - 144h (Lamotrigine)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0064636
UMLS CUI-4
C0178602
UMLS CUI-5
C0011008
UMLS CUI-6
C0040223
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint
Beschrijving

Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0064636
UMLS CUI [2]
C2348792
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Actual date/time
Beschrijving

Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Actual date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0064636
UMLS CUI [2]
C1264639
Terug naar het begin van de pagina

Similar models

Visit 1 - Randomisation Number; 12-Lead ECG; 12-Lead ECG Abnormalities; Vital Signs; Investigational Product; Treatment Confirmation; Electronically Transferred Lab Data; Pharmacokinetics Blood

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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
Randomisation
C0034656 (UMLS CUI-1)
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12-Lead ECG - Dosing Date and Time
Item
12-Lead ECG - Dosing Date and Time
datetime
C0430456 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0430456 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Date and Time of ECG (Pre-dose)
Item
Date and Time of ECG (Pre-dose)
datetime
C2826846 (UMLS CUI [1])
C0439565 (UMLS CUI [2])
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
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
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, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE)  (3)
CL Item
No result (not available) (4)
Item Group
12-Lead ECG Abnormalities
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 (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])
Item
B. P-Wave Morphology
text
C2216025 (UMLS CUI [1])
B. P-Wave Morphology
Code List
B. P-Wave Morphology
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])
Item
C. Conduction
text
C0232217 (UMLS CUI [1])
C. Conduction
Code List
C. Conduction
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])
Item
D. Myocardial Infarction
text
C0027051 (UMLS CUI [1])
D. Myocardial Infarction
Code List
D. Myocardial Infarction
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])
Item
E. Depolarisation/Repolarisation (QRS-T)
text
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 (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])
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])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs - Dosing date/time
Item
Vital Signs - Dosing date/time
datetime
C0518766 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0518766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Vital Signs - Actual date/time (Pre-dose)
Item
Vital Signs - Actual date/time (Pre-dose)
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Investigational product - Date/time of dose
Item
Investigational product - Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Did the subject receive the correct treatment
Item
Did the subject receive the correct treatment ( e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If subject did not receive the correct treatment, record reason
Item
If subject did not receive the correct treatment, record reason
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
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])
Item
Haematology sample not taken
integer
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Haematology sample not taken
Code List
Haematology sample not taken
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])
Item
Clinical Chemistry sample not taken
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Clinical Chemistry sample not taken
Code List
Clinical Chemistry sample not taken
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])
Clinical Chemistry same as the Haematology sample
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])
Item
Urinalysis sample not taken.
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis sample not taken.
Code List
Urinalysis sample not taken.
CL Item
Not done (1)
Item Group
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
Item
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Pharmacokinetics Blood Pre-36h (Lamotrigine)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Item
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint
Code List
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint
CL Item
Pre-Dose (1)
CL Item
0.5h (2)
CL Item
1h (3)
CL Item
2h (4)
CL Item
3h (5)
CL Item
4h (6)
CL Item
6h (7)
CL Item
8h (8)
CL Item
10h (9)
CL Item
12h (10)
CL Item
13h (11)
CL Item
14h (12)
CL Item
15h (13)
CL Item
16h (14)
CL Item
18h (15)
CL Item
20h (16)
CL Item
22h (17)
CL Item
24h (18)
CL Item
26h (19)
CL Item
36h (20)
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Actual date/time
Item
Pharmacokinetics Blood Pre-36h (Lamotrigine) - Actual date/time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C1264639 (UMLS CUI [2])
Item Group
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
Item
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Pharmacokinetics Blood 48h - 144h (Lamotrigine)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0064636 (UMLS CUI-3)
C0178602 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Item
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C2348792 (UMLS CUI [2])
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint
Code List
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint
CL Item
48h (1)
CL Item
72h (2)
CL Item
96h (3)
CL Item
120h (4)
CL Item
144h (5)
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Actual date/time
Item
Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Actual date/time
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
C1264639 (UMLS CUI [2])
Terug naar het begin van de pagina 

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial