ID

37680

Beschreibung

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

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  1. 16.08.19 16.08.19 -
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GlaxoSmithKline

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16. August 2019

DOI

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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)

Englisch

Logs/ Repeats - Concomitant Medication; 12-Lead/ Holter/ Telemetry ECG; 12-Lead ECG Abnormalities

1 Formulare  
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant Medication - Sequence number
Beschreibung

Concomitant Medication - Sequence number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Concomitant Medication - Drug Name
Beschreibung

(Trade Name preferred)

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Concomitant Medication - Modified reported term
Beschreibung

Concomitant Medicatin - Modified reported term

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826819
GSK Drug synonym
Beschreibung

GSK Drug synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Beschreibung

GSK Drug Collection code

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Concomitant Medication - Failed coding
Beschreibung

Concomitant Medication - Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Concomitant Medication Unit Dose
Beschreibung

Concomitant Medication Unit Dose

Datentyp

text

Alias
UMLS CUI [1]
C2826646
Concomitant Medication Units
Beschreibung

Concomitant Medication Units

Datentyp

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Concomitant Medication Frequency
Beschreibung

Concomitant Medication Frequency

Datentyp

integer

Alias
UMLS CUI [1]
C2826654
Concomitant Medication Route
Beschreibung

Concomitant Medication Route

Datentyp

integer

Alias
UMLS CUI [1]
C2826730
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Medication Start Date and Time
Beschreibung

Medication Start Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1301880
Medication taken Prior to Study?
Beschreibung

Medication taken Prior to Study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
Concomitant medication ongoing?
Beschreibung

Concomitant medication ongoing?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
End date and time of concomitant medication
Beschreibung

End date and time of concomitant medication

Datentyp

datetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2]
C1522314
12-Lead/ Holter/ Telemetry ECG
Beschreibung

12-Lead/ Holter/ Telemetry ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0013801
UMLS CUI-3
C1623258
UMLS CUI-4
C0039451
Date and Time of ECG
Beschreibung

Date and Time of ECG

Datentyp

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR lnterval
Beschreibung

PR lnterval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT lnterval
Beschreibung

Uncorrected QT lnterval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Beschreibung

QTc Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Beschreibung

Method of QTc Calculation

Datentyp

integer

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

Result of the ECG

Datentyp

integer

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

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
Date and Time of ECG
Beschreibung

Date and Time of ECG

Datentyp

datetime

Alias
UMLS CUI [1]
C2826846
A. Rhythm
Beschreibung

Record clinically significant abnormalities

Datentyp

text

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

A. If other abnormal rhythm, enter comment

Datentyp

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
Beschreibung

Record clinically significant abnormalities

Datentyp

text

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

B. If other morphology, enter comment

Datentyp

text

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

C. Conduction

Datentyp

text

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

C. If other conduction, enter comment

Datentyp

text

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

D. Myocardial Infarction

Datentyp

text

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

D. If other myocardial infarction, enter comment

Datentyp

text

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

E. Depolarisation/Repolarisation (QRS-T)

Datentyp

text

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

E. If other depolarisation/ repolarisation, enter comment

Datentyp

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
Beschreibung

If other abnormalities, enter comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0947611
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Ähnliche Modelle

Logs/ Repeats - Concomitant Medication; 12-Lead/ Holter/ Telemetry ECG; 12-Lead ECG Abnormalities

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication - Sequence number
Item
Concomitant Medication - Sequence number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Medication - Drug Name
Item
Concomitant Medication - Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medicatin - Modified reported term
Item
Concomitant Medication - Modified reported term
text
C2347852 (UMLS CUI [1,1])
C2826819 (UMLS CUI [1,2])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Concomitant Medication - Failed coding
Item
Concomitant Medication - Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Concomitant Medication Unit Dose
Item
Concomitant Medication Unit Dose
text
C2826646 (UMLS CUI [1])
Item
Concomitant Medication Units
integer
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Units
Code List
Concomitant Medication Units
CL Item
Actuation  (1)
CL Item
Ampoule  (2)
CL Item
Application  (3)
CL Item
Area under curve  (4)
CL Item
Bottle  (5)
CL Item
Capsule  (6)
CL Item
Cubic centimeter  (7)
CL Item
Cup  (8)
CL Item
Gamma per kilogram per minute (9)
CL Item
Gram  (10)
CL Item
Drops  (11)
CL Item
100 International units/ml (12)
CL Item
Inhalation  (13)
CL Item
International units (14)
CL Item
International units per kilogram (15)
CL Item
International units per kilogram per hour  (16)
CL Item
International units per millilitre  (17)
CL Item
Litre (18)
CL Item
Lozenge  (19)
CL Item
Litre per minute  (20)
CL Item
Minimum alveolar concentration  (21)
CL Item
Mega becquerels (MBq) MBQ  (22)
CL Item
Microgram (MCG) (23)
CL Item
Micrograms per hour  (24)
CL Item
Microgram/kilogram  (25)
CL Item
Microgram/kilogram per minute  (26)
CL Item
Micrograms per minute  (27)
CL Item
Micrograms per millitre  (28)
CL Item
Microlitre  (29)
CL Item
Milliequivalent  (30)
CL Item
Milliequivalent per 24  (31)
CL Item
Milligram  (32)
CL Item
Milligram per day  (33)
CL Item
Milligram per hour  (34)
CL Item
Milligram/kilogram  (35)
CL Item
Milligram/kilogram per hour  (36)
CL Item
Milligram/kilogram per minute  (37)
CL Item
Milligram/metre squared  (38)
CL Item
Milligram/millilitre  (39)
CL Item
Milligrams percent  (40)
CL Item
Million international units  (41)
CL Item
Millilitre  (42)
CL Item
Millilitre per hour  (43)
CL Item
Millilitre per minute  (44)
CL Item
Millimole  (45)
CL Item
Megaunits (million units)  (46)
CL Item
Nebule  (47)
CL Item
Ounce  (48)
CL Item
Patch  (49)
CL Item
Percent  (50)
CL Item
Puff  (51)
CL Item
Sachet  (52)
CL Item
Spray  (53)
CL Item
Suppository  (54)
CL Item
Tablet (55)
CL Item
Tablespoon  (56)
CL Item
Teaspoon  (57)
CL Item
Microgram (UG)  (58)
CL Item
Units per hour  (59)
CL Item
Units per kilogram per minute  (60)
CL Item
Units per minute  (61)
CL Item
Units  (62)
CL Item
Unknown  (63)
CL Item
Vial  (64)
Item
Concomitant Medication Frequency
integer
C2826654 (UMLS CUI [1])
Frequency
Code List
Concomitant Medication Frequency
CL Item
2 times per week  (1)
CL Item
3 times per week  (2)
CL Item
4 times per week  (3)
CL Item
5 times per day  (4)
CL Item
5 times per week  (5)
CL Item
AC  (6)
CL Item
BID  (7)
CL Item
Continuous infusion  (8)
CL Item
HS  (9)
CL Item
Once daily  (10)
CL Item
Once only (11)
CL Item
PC  (12)
CL Item
PRN  (13)
CL Item
Q12H  (14)
CL Item
Q2H  (15)
CL Item
Every 2 weeks  (16)
CL Item
Q3D  (17)
CL Item
Every 3 months  (18)
CL Item
Every 3 weeks  (19)
CL Item
Q4D  (20)
CL Item
Q4H  (21)
CL Item
Q6H  (22)
CL Item
Q8H  (23)
CL Item
QAM  (24)
CL Item
QH  (25)
CL Item
QID  (26)
CL Item
Once a month  (27)
CL Item
Every other day  (28)
CL Item
QPM  (29)
CL Item
Once a week  (30)
CL Item
TID  (31)
CL Item
Unknown (32)
Item
Concomitant Medication Route
integer
C2826730 (UMLS CUI [1])
Route
Code List
Concomitant Medication Route
CL Item
Epidural (1)
CL Item
Gastrostomy tube (2)
CL Item
Intra-arterial  (3)
CL Item
Intra-articular  (4)
CL Item
Intra-bursa (5)
CL Item
Intradermal  (6)
CL Item
Inhalation  (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Injection (11)
CL Item
Intraocular (12)
CL Item
Intraosteal (13)
CL Item
Intraperitoneal (14)
CL Item
Intrathecal (15)
CL Item
Intrauterine (16)
CL Item
Intravenous (17)
CL Item
Nasogastric (18)
CL Item
Nasal (19)
CL Item
Right eye (20)
CL Item
Ophthalmic  (21)
CL Item
Left eye (22)
CL Item
Otic (23)
CL Item
Other (24)
CL Item
Both eyes (25)
CL Item
Oral (26)
CL Item
Rectal (27)
CL Item
Subcutaneous (28)
CL Item
Sublingual (29)
CL Item
Transdermal (30)
CL Item
Topical (31)
CL Item
Unknown (32)
CL Item
Vaginal (33)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Start Date and Time
Item
Medication Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Medication taken Prior to Study?
Item
Medication taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant medication ongoing?
Item
Concomitant medication ongoing?
boolean
C2826666 (UMLS CUI [1])
End date and time of concomitant medication
Item
End date and time of concomitant medication
datetime
C2826744 (UMLS CUI [1])
C1522314 (UMLS CUI [2])
Item Group
12-Lead/ Holter/ Telemetry ECG
C0430456 (UMLS CUI-1)
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])
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 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)
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])
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