ID

44907

Beschreibung

https://clinicaltrials.gov/show/NCT00989664 Eligibility check Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Link

https://clinicaltrials.gov/show/NCT00989664

Stichworte

Versionen (2)
  1. 18.05.18 18.05.18 - Halim Ugurlu
  2. 06.04.22 06.04.22 - Martin Dugas
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

6. April 2022

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy

Englisch

Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7

1 Formulare  
  1. StudyEvent: Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy
    1. Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Site Number:
Beschreibung

Site Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient Number
Beschreibung

Patient Number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Laboratory Results Baseline
Beschreibung

Laboratory Results Baseline

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Hematology Date
Beschreibung

Hematology Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0011008
Lab # (Worksheet B)
Beschreibung

Lab Nr.

Datentyp

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0022877
WBC
Beschreibung

WBC

Datentyp

float

Alias
UMLS CUI [1]
C0023508
RBC
Beschreibung

RBC

Datentyp

float

Alias
UMLS CUI [1]
C0014772
Hemoglobin
Beschreibung

Hemoglobin

Datentyp

float

Alias
UMLS CUI [1]
C0019046
Hematocrit
Beschreibung

Hematocrit

Datentyp

float

Alias
UMLS CUI [1]
C0518014
Platelets
Beschreibung

Platelets

Datentyp

float

Alias
UMLS CUI [1]
C0005821
Neutrophils
Beschreibung

Neutrophils

Datentyp

float

Alias
UMLS CUI [1]
C0200633
Lymphocytes
Beschreibung

Lymphocytes

Datentyp

float

Alias
UMLS CUI [1]
C0200635
Monocytes
Beschreibung

Monocytes

Datentyp

float

Alias
UMLS CUI [1]
C0200637
Eosinophils
Beschreibung

Eosinophils

Datentyp

float

Alias
UMLS CUI [1]
C0200638
Basophils
Beschreibung

Basophils

Datentyp

float

Alias
UMLS CUI [1]
C0200641
Other Differential
Beschreibung

Other Differential

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0205394
Absolute Neutrophile Count-ANC (10³/mm³)
Beschreibung

ANC-Absolute Neutrophile Count

Datentyp

float

Maßeinheiten
  • 10³/mm³
Alias
UMLS CUI [1]
C0948762
10³/mm³
Laboratory Tests-Blood Chemistry
Beschreibung

Laboratory Tests-Blood Chemistry

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0005774
Chemistry Date
Beschreibung

Chemistry Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005774
Lab # (Worksheet B)
Beschreibung

Lab Nr.

Datentyp

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0022877
Sodium
Beschreibung

Sodium

Datentyp

float

Alias
UMLS CUI [1]
C0337443
Potassium
Beschreibung

Potassium

Datentyp

float

Alias
UMLS CUI [1]
C0202194
Chloride
Beschreibung

Chloride

Datentyp

float

Alias
UMLS CUI [1]
C0201952
BUN
Beschreibung

BUN

Datentyp

float

Alias
UMLS CUI [1]
C0005845
Creatinine
Beschreibung

Creatinine

Datentyp

float

Alias
UMLS CUI [1]
C0201976
AST (SGOT)
Beschreibung

AST (SGOT)

Datentyp

float

Alias
UMLS CUI [1]
C0201899
ALT (SGPT)
Beschreibung

ALT (SGPT)

Datentyp

float

Alias
UMLS CUI [1]
C0201836
Alkaline Phosphatase
Beschreibung

Alkaline Phosphatase

Datentyp

float

Alias
UMLS CUI [1]
C0201850
LDH
Beschreibung

LDH

Datentyp

float

Alias
UMLS CUI [1]
C0202113
Total Bilirubin
Beschreibung

Total Bilirubin

Datentyp

float

Alias
UMLS CUI [1]
C0201913
TSH
Beschreibung

TSH

Datentyp

float

Alias
UMLS CUI [1]
C0202230
Total T3
Beschreibung

Thyroid Tests may also be: T3U=T3 Uptake T3F=Free T3 T4T=Total T4

Datentyp

float

Alias
UMLS CUI [1]
C0428419
Free T4
Beschreibung

Thyroid Tests may also be: T3U=T3 Uptake T3F=Free T3 T4T=Total T4

Datentyp

float

Alias
UMLS CUI [1]
C0202225
Pregnancy Test
Beschreibung

Pregnancy Test

Alias
UMLS CUI-1
C0032976
N/A
Beschreibung

N/A

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1272460
UMLS CUI [1,2]
C0032976
Date
Beschreibung

Must be obtained within 7 days of study entry

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032976
Sample
Beschreibung

Sample

Datentyp

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0032976
Result
Beschreibung

Result

Datentyp

integer

Alias
UMLS CUI [1]
C0427777
Beta-2 Microglobulin (Serum)
Beschreibung

Beta-2 Microglobulin (Serum)

Alias
UMLS CUI-1
C0005149
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0005149
Result
Beschreibung

Result

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0005149
Infusion Record Dosimetric Dose - Day 0 and Day 7
Beschreibung

Infusion Record Dosimetric Dose - Day 0 and Day 7

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C2094191
Date Administered
Beschreibung

Date Administered

Datentyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Baseline HAMA (human antimurine antibody)
Beschreibung

Baseline HAMA (human antimurine antibody)

Alias
UMLS CUI-1
C1291910
UMLS CUI-2
C1442488
Baseline HAMA date
Beschreibung

Baseline HAMA date

Datentyp

date

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0011008
Baseline HAMA Result
Beschreibung

Baseline HAMA Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C1291910
UMLS CUI [1,3]
C1274040
Dosimetric Dose
Beschreibung

Dosimetric Dose

Alias
UMLS CUI-1
C2094191
Time Started (24 hour clock) (cold)
Beschreibung

Time Started (cold)

Datentyp

time

Alias
UMLS CUI [1]
C1301880
Time Finished (24 hour clock) (cold)
Beschreibung

Time Finished (24 hour clock) (cold)

Datentyp

time

Alias
UMLS CUI [1]
C1522314
Time Started (24 hour clock) (cold flush)
Beschreibung

Time Started (24 hour clock) (cold flush)

Datentyp

time

Alias
UMLS CUI [1]
C1301880
Time Finished (24 hour clock) (cold flush)
Beschreibung

Time Finished (24 hour clock) (cold flush)

Datentyp

time

Alias
UMLS CUI [1]
C1522314
Time Started (24 hour clock) (hot)
Beschreibung

Time Started (24 hour clock) (hot)

Datentyp

time

Alias
UMLS CUI [1]
C1301880
Time Finished (24 hour clock) (hot)
Beschreibung

Time Finished (24 hour clock) (hot)

Datentyp

time

Alias
UMLS CUI [1]
C1522314
Time Started (24 hour clock) (hot flush)
Beschreibung

Time Started (24 hour clock) (hot flush)

Datentyp

time

Alias
UMLS CUI [1]
C1301880
Time Finished (24 hour clock) (hot flush)
Beschreibung

Time Finished (24 hour clock) (hot flush)

Datentyp

time

Alias
UMLS CUI [1]
C1522314
Anti-B1 Dose
Beschreibung

Anti-B1 Dose

Alias
UMLS CUI-1
C0768182
UMLS CUI-2
C3174092
Anti-B1 Dose (cold dose)
Beschreibung

Anti-B1 Dose (cold dose)

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C3174092
mg
Lot number of Anti-B1 (cold)
Beschreibung

Lot number of Anti-B1 (cold)

Datentyp

text

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C0768182
Anti-B1 Dose (hot dose)
Beschreibung

Anti-B1 Dose (hot dose)

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C3174092
mg
Lot number of Anti-B1 (hot)
Beschreibung

Lot number of Anti-B1 (hot)

Datentyp

text

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C0768182
Iodine-131 Anti-B1 (prescribed)
Beschreibung

Iodine-131 Anti-B1 (prescribed)

Datentyp

text

Alias
UMLS CUI [1]
C0768182
Lot Number (Nordion)
Beschreibung

Lot Number (Nordion)

Datentyp

text

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C3854006
Infusion Rate
Beschreibung

Infusion Rate

Alias
UMLS CUI-1
C2964135
Did infusion rate need to be adjusted?
Beschreibung

Infusion rate need to be adjusted?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C2826232
If yes, was infusion rate
Beschreibung

If yes, was infusion rate

Datentyp

integer

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C2826232
If the infusion rate was adjusted, was it for (check all that apply)
Beschreibung

If the infusion rate was adjusted, was it for (check all that apply)

Datentyp

integer

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C2826232
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Time (24 hr)
Beschreibung

Time (24 hr)

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Blood Pressure (mmhg)
Beschreibung

BP

Datentyp

text

Alias
UMLS CUI [1]
C0005823
Pulse
Beschreibung

Pulse

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temp. (C)
Beschreibung

Temp

Datentyp

float

Alias
UMLS CUI [1]
C0005903
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Adverse Experiences
Beschreibung

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Did the patient have any adverse experiences? (If yes, please record on AE page)
Beschreibung

If yes, please record on AE page

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
(Note; only Day 7) Was patient compliant with SSKI, Lugol`s solution or Potassium iodide as described in protocol?
Beschreibung

(Note; only Day 7) Compliance with SSKI, Lugol`s solution or Potassium iodide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0032831
UMLS CUI [1,3]
C0065234
(Note; only Day 7) If No to previous question please explain
Beschreibung

(Note; only Day 7) If No to previous question please explain

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0681841
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Ähnliche Modelle

Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7

1 Formulare
  1. StudyEvent: Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy
    1. Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number:
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Laboratory Results Baseline
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Hematology Date
Item
Hematology Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Lab Nr.
Item
Lab # (Worksheet B)
text
C1300638 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
WBC
Item
WBC
float
C0023508 (UMLS CUI [1])
RBC
Item
RBC
float
C0014772 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0200637 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Other Differential
Item
Other Differential
text
C0022885 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ANC-Absolute Neutrophile Count
Item
Absolute Neutrophile Count-ANC (10³/mm³)
float
C0948762 (UMLS CUI [1])
Item Group
Laboratory Tests-Blood Chemistry
C1254595 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
Chemistry Date
Item
Chemistry Date
date
C0011008 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
Lab Nr.
Item
Lab # (Worksheet B)
text
C1300638 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
TSH
Item
TSH
float
C0202230 (UMLS CUI [1])
Total T3
Item
Total T3
float
C0428419 (UMLS CUI [1])
Free T4
Item
Free T4
float
C0202225 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
N/A
Item
N/A
boolean
C1272460 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
Sample
integer
C0200345 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Sample
Code List
Sample
CL Item
Urine (1)
CL Item
Serum (2)
Item
Result
integer
C0427777 (UMLS CUI [1])
Result
Code List
Result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Beta-2 Microglobulin (Serum)
C0005149 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0005149 (UMLS CUI [1,3])
Result
Item
Result
text
C1274040 (UMLS CUI [1,1])
C0005149 (UMLS CUI [1,2])
Item Group
Infusion Record Dosimetric Dose - Day 0 and Day 7
C0574032 (UMLS CUI-1)
C2094191 (UMLS CUI-2)
Date Administered
Item
Date Administered
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Baseline HAMA (human antimurine antibody)
C1291910 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Baseline HAMA date
Item
Baseline HAMA date
date
C1291910 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Baseline HAMA Result
integer
C1442488 (UMLS CUI [1,1])
C1291910 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Baseline HAMA Result
Code List
Baseline HAMA Result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Dosimetric Dose
C2094191 (UMLS CUI-1)
Time Started (cold)
Item
Time Started (24 hour clock) (cold)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (cold)
Item
Time Finished (24 hour clock) (cold)
time
C1522314 (UMLS CUI [1])
Time Started (24 hour clock) (cold flush)
Item
Time Started (24 hour clock) (cold flush)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (cold flush)
Item
Time Finished (24 hour clock) (cold flush)
time
C1522314 (UMLS CUI [1])
Time Started (24 hour clock) (hot)
Item
Time Started (24 hour clock) (hot)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (hot)
Item
Time Finished (24 hour clock) (hot)
time
C1522314 (UMLS CUI [1])
Time Started (24 hour clock) (hot flush)
Item
Time Started (24 hour clock) (hot flush)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (hot flush)
Item
Time Finished (24 hour clock) (hot flush)
time
C1522314 (UMLS CUI [1])
Item Group
Anti-B1 Dose
C0768182 (UMLS CUI-1)
C3174092 (UMLS CUI-2)
Anti-B1 Dose (cold dose)
Item
Anti-B1 Dose (cold dose)
float
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Lot number of Anti-B1 (cold)
Item
Lot number of Anti-B1 (cold)
text
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
Anti-B1 Dose (hot dose)
Item
Anti-B1 Dose (hot dose)
float
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Lot number of Anti-B1 (hot)
Item
Lot number of Anti-B1 (hot)
text
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
Iodine-131 Anti-B1 (prescribed)
Item
Iodine-131 Anti-B1 (prescribed)
text
C0768182 (UMLS CUI [1])
Lot Number (Nordion)
Item
Lot Number (Nordion)
text
C1115660 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Item Group
Infusion Rate
C2964135 (UMLS CUI-1)
Infusion rate need to be adjusted?
Item
Did infusion rate need to be adjusted?
boolean
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
Item
If yes, was infusion rate
integer
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
If yes, was infusion rate
Code List
If yes, was infusion rate
CL Item
Decreased by 1/2 (1)
CL Item
discontinued (2)
CL Item
other (3)
Item
If the infusion rate was adjusted, was it for (check all that apply)
integer
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
If the infusion rate was adjusted, was it for (check all that apply)
Code List
If the infusion rate was adjusted, was it for (check all that apply)
CL Item
low SBP (1)
CL Item
rigors (2)
CL Item
fever (3)
CL Item
mucosal congestion/edema (4)
CL Item
other (5)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Time (24 hr)
Item
Time (24 hr)
time
C0040223 (UMLS CUI [1])
BP
Item
Blood Pressure (mmhg)
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temp
Item
Temp. (C)
float
C0005903 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Did the patient have any adverse experiences?
Item
Did the patient have any adverse experiences? (If yes, please record on AE page)
boolean
C0877248 (UMLS CUI [1])
(Note; only Day 7) Compliance with SSKI, Lugol`s solution or Potassium iodide
Item
(Note; only Day 7) Was patient compliant with SSKI, Lugol`s solution or Potassium iodide as described in protocol?
boolean
C1321605 (UMLS CUI [1,1])
C0032831 (UMLS CUI [1,2])
C0065234 (UMLS CUI [1,3])
(Note; only Day 7) If No to previous question please explain
Item
(Note; only Day 7) If No to previous question please explain
text
C0947611 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
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