ID

40328

Description

Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity

Keywords

Versions (1)
  1. 4/8/20 4/8/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 8, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883

English

Vitals; PK; Dosing; Medications; Concomitant Medication

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Study
Description

Study

Data type

text

Alias
UMLS CUI [1]
C2603343
Subject
Description

Name and volunteer ID of volunteer

Data type

text

Alias
UMLS CUI [1]
C0681850
Collected by
Description

User ID of data collector

Data type

text

Alias
UMLS CUI [1]
C3244127
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Phase
Description

Study Phase

Data type

text

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C2603343
Session
Description

Session

Data type

text

Alias
UMLS CUI [1]
C1883017
Vitals
Description

Vitals

Alias
UMLS CUI-1
C0518766
Vitals - Collect Date
Description

Vitals - Collect Date

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Vitals - Collect Time
Description

Vitals - Collect Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Vitals - Day
Description

Vitals - Day

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439228
Vitals - Hour
Description

Vitals - Hour

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439227
h
Vials - Min
Description

Vials - Min

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439232
min
Vitals - Position
Description

Vitals - Position

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
Vitals - Use in Report
Description

Vitals - Use in Report

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0684224
Vitals - Unscheduled
Description

Vitals - Unscheduled

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C3854240
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Pulse
Description

Pulse

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature Source
Description

Temperature Source

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449416
Respiratory Rate
Description

Respiratory Rate

Data type

integer

Measurement units
  • r/min
Alias
UMLS CUI [1]
C0231832
r/min
SPCO2 %
Description

SPCO2 %

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0007012
%
Vitals - Date
Description

Vitals - Date

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Vitals - Time
Description

Vitals - Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Vitals - BP required
Description

Vitals - BP required

Data type

boolean

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0005823
UMLS CUI [3]
C1514873
Vitals - HR required
Description

Vitals - HR required

Data type

boolean

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0018810
UMLS CUI [3]
C1514873
Vitals - Temp. required
Description

Vitals - Temp. required

Data type

boolean

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0005903
UMLS CUI [3]
C1514873
Vitals - Resp. required
Description

Vitals - Resp. required

Data type

boolean

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0231832
UMLS CUI [3]
C1514873
Vitals - SPCO2 required
Description

Vitals - SPCO2 required

Data type

boolean

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0007012
UMLS CUI [3]
C1514873
Vitals - Collection Comment
Description

Vitals - Collection Comment

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0947611
PK
Description

PK

Alias
UMLS CUI-1
C0031327
PK - Collect Date
Description

PK - Collect Date

Data type

date

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C1317250
PK - Collect Time
Description

PK - Collect Time

Data type

time

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0040223
PK - Day
Description

PK - Day

Data type

text

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0439228
PK - Hour
Description

PK - Hour

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0439227
h
PK - Min
Description

PK - Min

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0439232
min
PK - Collection Comment
Description

PK - Collection Comment

Data type

text

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0947611
Dosing
Description

Dosing

Alias
UMLS CUI-1
C0178602
Dosing - Day
Description

Dosing - Day

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0439228
Dosing - Hour
Description

Dosing - Hour

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0439227
h
Dosing - Min
Description

Dosing - Min

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0439232
min
Dosing - Date Dose Administered
Description

Dosing - Date Dose Administered

Data type

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Dosing - Time Dose Administered
Description

Dosing - Time Dose Administered

Data type

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Dosing - Drug
Description

Dosing - Drug

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0013227
Dosing Confirmed By:
Description

UserID of user who confirms dose is correct.

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750484
Medications - Drug
Description

Medications - Drug

Alias
UMLS CUI-1
C0013227
Prior Medication - Collection Date
Description

Prior Medication - Collection Date

Data type

date

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C1317250
Prior Medication - Time
Description

Prior Medication - Time

Data type

time

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0040223
There were no prior medications for this subject
Description

There were no prior medications for this subject

Data type

boolean

Alias
UMLS CUI [1]
C2826257
Prior Medication - Drug Name
Description

Prior Medication - Drug Name

Data type

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2360065
Prior Medication - Drug Dose
Description

Prior Medication - Drug Dose

Data type

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0678766
Prior Medication - Route
Description

Prior Medication - Route

Data type

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0013153
Prior Medication - Indication
Description

Prior Medication - Indication

Data type

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C3146298
Prior Medication - Duration
Description

Prior Medication - Duration

Data type

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0449238
Prior Medication - Stop Date
Description

Prior Medication - Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0806020
Prior Medication - Stop Time
Description

Prior Medication - Stop Time

Data type

time

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C1522314
Prior Medication - Continuing During Study
Description

Prior Medication - Continuing During Study

Data type

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0549178
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant Medication - Collection Date
Description

Concomitant Medication - Collection Date

Data type

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1317250
Concomitant Medication - Collect Time
Description

Concomitant Medication - Collect Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0552379
There were no concomitant medications for this subject
Description

There were no concomitant medications for this subject

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medication - Drug Name
Description

Concomitant Medication - Drug Name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Concomitant Medication - Dose/Unit
Description

Concomitant Medication - Dose/Unit

Data type

text

Alias
UMLS CUI [1]
C2826646
Concomitant Medication - Freq/Day
Description

Concomitant Medication - Freq/Day

Data type

integer

Alias
UMLS CUI [1]
C2826654
Concomitant Medication - Route
Description

Concomitant Medication - Route

Data type

text

Alias
UMLS CUI [1]
C2826730
Concomitant Medication - Indication
Description

Concomitant Medication - Indication

Data type

text

Alias
UMLS CUI [1]
C2826696
Concomitant Medication - Taken to treat AE?
Description

Concomitant Medication - Taken to treat AE?

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2981656
Concomitant Medication - Start Date
Description

Concomitant Medication - Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Concomitant Medication - Start Time
Description

Concomitant Medication - Start Time

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2347852
Concomitant Medication - Stop Date
Description

Concomitant Medication - Stop Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Concomitant Medication - Stop Time
Description

Concomitant Medication - Stop Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1522314
Concomitant Medication - Continuing
Description

Concomitant Medication - Continuing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Vitals; PK; Dosing; Medications; Concomitant Medication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study
Item
Study
text
C2603343 (UMLS CUI [1])
Subject
Item
Subject
text
C0681850 (UMLS CUI [1])
Collected by
Item
Collected by
text
C3244127 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Study Phase
Item
Study Phase
text
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Session
Item
Session
text
C1883017 (UMLS CUI [1])
Item Group
Vitals
C0518766 (UMLS CUI-1)
Vitals - Collect Date
Item
Vitals - Collect Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Vitals - Collect Time
Item
Vitals - Collect Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Vitals - Day
Item
Vitals - Day
text
C0518766 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Vitals - Hour
Item
Vitals - Hour
integer
C0518766 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Vials - Min
Item
Vials - Min
integer
C0518766 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Item
Vitals - Position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Vitals - Position
Code List
Vitals - Position
CL Item
Sitting (SI)
CL Item
Supine (Leg) (SL)
CL Item
Semi supine (SS)
CL Item
Standing (ST)
CL Item
Supine (SU)
Vitals - Use in Report
Item
Vitals - Use in Report
text
C0518766 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
Vitals - Unscheduled
Item
Vitals - Unscheduled
text
C0518766 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Temperature Source
Item
Temperature Source
text
C0005903 (UMLS CUI [1,1])
C0449416 (UMLS CUI [1,2])
Respiratory Rate
Item
Respiratory Rate
integer
C0231832 (UMLS CUI [1])
SPCO2 %
Item
SPCO2 %
integer
C0007012 (UMLS CUI [1])
Vitals - Date
Item
Vitals - Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Vitals - Time
Item
Vitals - Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Vitals - BP required
Item
Vitals - BP required
boolean
C0518766 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
C1514873 (UMLS CUI [3])
Vitals - HR required
Item
Vitals - HR required
boolean
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
C1514873 (UMLS CUI [3])
Vitals - Temp. required
Item
Vitals - Temp. required
boolean
C0518766 (UMLS CUI [1])
C0005903 (UMLS CUI [2])
C1514873 (UMLS CUI [3])
Vitals - Resp. required
Item
Vitals - Resp. required
boolean
C0518766 (UMLS CUI [1])
C0231832 (UMLS CUI [2])
C1514873 (UMLS CUI [3])
Vitals - SPCO2 required
Item
Vitals - SPCO2 required
boolean
C0518766 (UMLS CUI [1])
C0007012 (UMLS CUI [2])
C1514873 (UMLS CUI [3])
Vitals - Collection Comment
Item
Vitals - Collection Comment
text
C0518766 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
PK
C0031327 (UMLS CUI-1)
PK - Collect Date
Item
PK - Collect Date
date
C0031327 (UMLS CUI [1,1])
C1317250 (UMLS CUI [1,2])
PK - Collect Time
Item
PK - Collect Time
time
C0031327 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
PK - Day
Item
PK - Day
text
C0031327 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
PK - Hour
Item
PK - Hour
integer
C0031327 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
PK - Min
Item
PK - Min
integer
C0031327 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
PK - Collection Comment
Item
PK - Collection Comment
text
C0031327 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Dosing
C0178602 (UMLS CUI-1)
Dosing - Day
Item
Dosing - Day
text
C0178602 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Dosing - Hour
Item
Dosing - Hour
integer
C0178602 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Dosing - Min
Item
Dosing - Min
integer
C0178602 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Dosing - Date Dose Administered
Item
Dosing - Date Dose Administered
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Dosing - Time Dose Administered
Item
Dosing - Time Dose Administered
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dosing - Drug
Item
Dosing - Drug
text
C0178602 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Dosing Confirmed By:
Item
Dosing Confirmed By:
text
C0178602 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Item Group
Medications - Drug
C0013227 (UMLS CUI-1)
Prior Medication - Collection Date
Item
Prior Medication - Collection Date
date
C2826257 (UMLS CUI [1,1])
C1317250 (UMLS CUI [1,2])
Prior Medication - Time
Item
Prior Medication - Time
time
C2826257 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
There were no prior medications for this subject
Item
There were no prior medications for this subject
boolean
C2826257 (UMLS CUI [1])
Prior Medication - Drug Name
Item
Prior Medication - Drug Name
text
C2826257 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Prior Medication - Drug Dose
Item
Prior Medication - Drug Dose
text
C2826257 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
Item
Prior Medication - Route
text
C2826257 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Prior Medication - Route
Code List
Prior Medication - Route
CL Item
Intra-Arterial (IAR)
CL Item
Intracoronary (IC)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intranasal (IN)
CL Item
Infiltration (INF)
CL Item
Intraocular (IO)
CL Item
Intraperitoneal (IP)
CL Item
Intrapleural (IPL)
CL Item
Irrigate (IR)
CL Item
Intravenous (IV)
CL Item
IV Bolus (IVB)
CL Item
Nasal (NA)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Prior Medication - Indication
Item
Prior Medication - Indication
text
C2826257 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Prior Medication - Duration
Item
Prior Medication - Duration
text
C2826257 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Prior Medication - Stop Date
Item
Prior Medication - Stop Date
date
C2826257 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Prior Medication - Stop Time
Item
Prior Medication - Stop Time
time
C2826257 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Prior Medication - Continuing During Study
Item
Prior Medication - Continuing During Study
text
C2826257 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication - Collection Date
Item
Concomitant Medication - Collection Date
date
C2347852 (UMLS CUI [1,1])
C1317250 (UMLS CUI [1,2])
Concomitant Medication - Collect Time
Item
Concomitant Medication - Collect Time
time
C2347852 (UMLS CUI [1,1])
C0552379 (UMLS CUI [1,2])
There were no concomitant medications for this subject
Item
There were no concomitant medications for this subject
boolean
C2347852 (UMLS CUI [1])
Concomitant Medication - Drug Name
Item
Concomitant Medication - Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medication - Dose/Unit
Item
Concomitant Medication - Dose/Unit
text
C2826646 (UMLS CUI [1])
Concomitant Medication - Freq/Day
Item
Concomitant Medication - Freq/Day
integer
C2826654 (UMLS CUI [1])
Item
Concomitant Medication - Route
text
C2826730 (UMLS CUI [1])
Concomitant Medication - Route
Code List
Concomitant Medication - Route
CL Item
Intra-arterial (IAR)
CL Item
Intracoronary (IC)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intranasal (IN)
CL Item
Infiltration (INF)
CL Item
Intraocular (IO)
CL Item
Intraperitoneal (IP)
CL Item
Intrapleural (IPL)
CL Item
Irrigate (IR)
CL Item
Intravenous (IV)
CL Item
IV Bolus (IVB)
CL Item
Nasal (NA)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Concomitant Medication - Indication
Item
Concomitant Medication - Indication
text
C2826696 (UMLS CUI [1])
Concomitant Medication - Taken to treat AE?
Item
Concomitant Medication - Taken to treat AE?
boolean
C2347852 (UMLS CUI [1,1])
C2981656 (UMLS CUI [1,2])
Concomitant Medication - Start Date
Item
Concomitant Medication - Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medication - Start Time
Item
Concomitant Medication - Start Time
time
C1301880 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medication - Stop Date
Item
Concomitant Medication - Stop Date
date
C2826744 (UMLS CUI [1])
Concomitant Medication - Stop Time
Item
Concomitant Medication - Stop Time
time
C2347852 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Concomitant Medication - Continuing
Item
Concomitant Medication - Continuing
boolean
C2826666 (UMLS CUI [1])
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