ID

25139

Description

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 2 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Mots-clés

Versions (1)
  1. 27/08/2017 27/08/2017 -
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glaxoSmithKline

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27 août 2017

DOI

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Creative Commons BY-NC 3.0
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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 2

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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 2

1 Formulaires  
Solicited Symptoms
Description

Solicited Symptoms

Alias
UMLS CUI-1
C0683368
UMLS CUI-2
C1517001
Redness
Description

Administration site erythema

Type de données

boolean

Alias
UMLS CUI [1]
C3805283
Size (of redness at administration site) Day 0
Description

Size of erythema at administration site Day 0

Type de données

integer

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Size (of redness at administration site) Day 1
Description

Size of erythema at administration site Day 1

Type de données

integer

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Size (of redness at administration site) Day 2
Description

Size of erythema at administration site Day 2

Type de données

integer

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Size (of redness at administration site) Day 3
Description

Size of erythema at administration site Day 3

Type de données

integer

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Ongoing after Day 3?
Description

Erythema ongoing after day 3

Type de données

boolean

Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Description

Date of last day of symptoms

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Swelling
Description

Administration site swelling

Type de données

boolean

Alias
UMLS CUI [1]
C3854415
Size (of swelling at administration site) Day 0
Description

Size of swelling at administration site Day 0

Type de données

integer

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Size (of swelling at administration site) Day 1
Description

Size of swelling at administration site Day 1

Type de données

integer

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Size (of swelling at administration site) Day 2
Description

Size of swelling at administration site Day 2

Type de données

integer

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Size (of swelling at administration site) Day 3
Description

Size of swelling at administration site Day 3

Type de données

integer

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Ongoing after day 3?
Description

Swelling ongoing after day 3

Type de données

boolean

Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Description

Date of last day of symptoms

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Pain
Description

Administration site pain

Type de données

boolean

Alias
UMLS CUI [1]
C0521491
Intensity (of pain at administration site) Day 0
Description

Intensity of pain at administration site Day 0

Type de données

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 1
Description

Intensity of pain at administration site Day 1

Type de données

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 2
Description

Intensity of pain at administration site Day 2

Type de données

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 3
Description

Intensity of pain at administration site Day 3

Type de données

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Temperature (day 0-day 14)
Description

Temperature (day 0-day 14)

Alias
UMLS CUI-1
C0039476
Route of measurement
Description

Please record axillary / rectal temperature daily from day 0 to day 14 after vaccination at bedtime. Only one route of temperature measurement should be used consistently. If temperature has been taken more than once a day, please report the highest value for the day.

Type de données

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Temperature (day 0-day 14)
Description

Temperature (day 0-day 14)

Alias
UMLS CUI-1
C0039476
Episode No.
Description

Fever Episode Number

Type de données

integer

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0439228
Temperature
Description

Temperature

Type de données

float

Unités de mesure
  • degree Celsius
Alias
UMLS CUI [1]
C0039476
degree Celsius
Medically attended Visit?
Description

Medically attended Visit

Type de données

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0015967
Temperature (day 15-day 42)
Description

Temperature (day 15-day 42)

Alias
UMLS CUI-1
C0039476
Day
Description

Day 15-42 Please screen temperature daily from day 15 to 42 please use the temperature sensitive pad or thermometer. If fever is indicated, please take the childís temperature using a thermometer and report measurement below. If multiple measures, take the maximum value.

Type de données

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0039476
Fever
Description

Fever

Type de données

boolean

Alias
UMLS CUI [1]
C0015967
Temperature
Description

Please screen temperature daily from day 15 to 42 please use the temperature sensitive pad or thermometer. If fever is indicated, please take the childís temperature using a thermometer and report measurement below. If multiple measures, take the maximum value.

Type de données

boolean

Alias
UMLS CUI [1]
C0039476
Medically attended visit
Description

Medically attended visit

Type de données

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332575
Rash / exanthema (day 0-day 42)
Description

Rash / exanthema (day 0-day 42)

Alias
UMLS CUI-1
C0015230
Episode No.
Description

Please provide information on rash/exantem below. During the visit, physician will ask about more details - e.g. its description (size, shape, colour, lay-out, location, itching, soreness, etc.) Do not report here Varicella (Chickenpox) or Zoster (Shingles) here, but report in the Varicella (Chickenpox) or Zoster Case (Shingles) diary card section.

Type de données

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0449788
Date started
Description

Start Date of rash

Type de données

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0808070
Date stopped
Description

End Date of rash

Type de données

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0806020
Intensity
Description

Intensity of rash

Type de données

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0518690
Parotid / Salivary gland swelling events (day 0-day 42)
Description

Parotid / Salivary gland swelling events (day 0-day 42)

Alias
UMLS CUI-1
C0240925
UMLS CUI-2
C0240668
Parotid swelling No.
Description

Please provide information on parotid/salivary gland swelling below. During the visit, physician will ask about more details - e.g. its description (size, reddish skin, soreness, etc.)

Type de données

integer

Alias
UMLS CUI [1,1]
C0240668
UMLS CUI [1,2]
C0449788
Date started
Description

Start date of parotid swelling

Type de données

date

Alias
UMLS CUI [1,1]
C0240668
UMLS CUI [1,2]
C0808070
Date stopped
Description

End date of parotid swelling

Type de données

date

Alias
UMLS CUI [1,1]
C0240668
UMLS CUI [1,2]
C0806020
Intensity
Description

Intensity of parotid swelling

Type de données

integer

Alias
UMLS CUI [1,1]
C0240668
UMLS CUI [1,2]
C0518690
Convulsion
Description

Convulsion

Alias
UMLS CUI-1
C4048158
Convulsion No.
Description

Please provide information on convulsions below. During the visit, physician will ask about more details - e.g. symptoms, description, etc.

Type de données

integer

Alias
UMLS CUI [1,1]
C4048158
UMLS CUI [1,2]
C0449788
Date and Time started
Description

Start date and time of febrile convulsion

Type de données

datetime

Alias
UMLS CUI [1,1]
C4048158
UMLS CUI [1,2]
C2826806
Date and Time stopped
Description

End date and time of febrile convulsion

Type de données

datetime

Alias
UMLS CUI [1,1]
C4048158
UMLS CUI [1,2]
C2826793
Fever
Description

Fever

Type de données

boolean

Alias
UMLS CUI [1]
C0015967
Unsolicited symptoms (day 0 - day 42)
Description

Unsolicited symptoms (day 0 - day 42)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C4055646
Description - please specify side(s) and site(s)
Description

Description of unsolicited symptom

Type de données

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C4055646
UMLS CUI [1,3]
C0678257
Intensity
Description

Intensity of unsolicited symptom

Type de données

integer

Alias
UMLS CUI [1,1]
C0234687
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C4055646
Start Date
Description

Start date of unsolicited event

Type de données

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C4055646
UMLS CUI [1,3]
C0808070
End Date
Description

End Date of unsolicited event

Type de données

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C4055646
UMLS CUI [1,3]
C0806020
Unsolicited symptom is continuing
Description

Unsolicited symptom continuing

Type de données

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C4055646
UMLS CUI [1,3]
C0549178
Medication (day 0 - day 42)
Description

Medication (day 0 - day 42)

Alias
UMLS CUI-1
C0013227
Trade / Generic name
Description

Please record all medication taken between Day 0 and Day 42 taken after Dose 1 according to the following criteria. All concomitant medication, with the exception of vitamins and/or dietary supplements, administered at ANY time during the period starting with administration of each dose of study vaccine and ending 43 days (Day 0 to Day 42) after each dose of study vaccine are to be recorded with name of the medication, reason for taking medication, total daily dose, start and end dates of treatment.

Type de données

text

Alias
UMLS CUI [1,1]
C0592503
UMLS CUI [1,2]
C0013227
Reason
Description

Medical indication for medication

Type de données

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Total daily dose
Description

Total daily dose

Type de données

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Start Date
Description

Start Date of medication

Type de données

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Description

End Date of Medication

Type de données

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuous medication
Description

Medication continuing

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Diary Card - Post Vaccination Dose 2

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Solicited Symptoms
C0683368 (UMLS CUI-1)
C1517001 (UMLS CUI-2)
Administration site erythema
Item
Redness
boolean
C3805283 (UMLS CUI [1])
Size of erythema at administration site Day 0
Item
Size (of redness at administration site) Day 0
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 1
Item
Size (of redness at administration site) Day 1
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 2
Item
Size (of redness at administration site) Day 2
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 3
Item
Size (of redness at administration site) Day 3
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Erythema ongoing after day 3
Item
Ongoing after Day 3?
boolean
C3805283 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Administration site swelling
Item
Swelling
boolean
C3854415 (UMLS CUI [1])
Size of swelling at administration site Day 0
Item
Size (of swelling at administration site) Day 0
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 1
Item
Size (of swelling at administration site) Day 1
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 2
Item
Size (of swelling at administration site) Day 2
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 3
Item
Size (of swelling at administration site) Day 3
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling ongoing after day 3
Item
Ongoing after day 3?
boolean
C3854415 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Administration site pain
Item
Pain
boolean
C0521491 (UMLS CUI [1])
Item
Intensity (of pain at administration site) Day 0
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 0
Code List
Intensity (of pain at administration site) Day 0
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved / spontaneously painful (3)
Item
Intensity (of pain at administration site) Day 1
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 1
Code List
Intensity (of pain at administration site) Day 1
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved / spontaneously painful (3)
Item
Intensity (of pain at administration site) Day 2
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 2
Code List
Intensity (of pain at administration site) Day 2
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved / spontaneously painful (3)
Item
Intensity (of pain at administration site) Day 3
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 3
Code List
Intensity (of pain at administration site) Day 3
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved / spontaneously painful (3)
Item Group
Temperature (day 0-day 14)
C0039476 (UMLS CUI-1)
Item
Route of measurement
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Fever
Code List
Route of measurement
CL Item
Axillary (A)
CL Item
Rectal (R)
Item Group
Temperature (day 0-day 14)
C0039476 (UMLS CUI-1)
Item
Episode No.
integer
C0015967 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Fever Episode Number
Code List
Episode No.
CL Item
Day 1 (01)
CL Item
Day 2 (02)
CL Item
Day 3 (03)
CL Item
Day 4 (04)
CL Item
Day 5 (05)
CL Item
Day 6 (06)
CL Item
Day 7 (07)
CL Item
Day 8 (08)
CL Item
Day 9 (09)
CL Item
Day 10 (10)
CL Item
Day 11 (11)
CL Item
Day 12 (12)
CL Item
Day 13 (13)
CL Item
Day 14 (14)
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Medically attended Visit
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Item Group
Temperature (day 15-day 42)
C0039476 (UMLS CUI-1)
Day
Item
Day
integer
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,3])
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Temperature
Item
Temperature
boolean
C0039476 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Item Group
Rash / exanthema (day 0-day 42)
C0015230 (UMLS CUI-1)
rash number of episode
Item
Episode No.
integer
C0015230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Start Date of rash
Item
Date started
date
C0015230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of rash
Item
Date stopped
date
C0015230 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
integer
C0015230 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of rash
Code List
Intensity
CL Item
1-50 lesions (1)
CL Item
51-100 lesions (2)
CL Item
101-500 lesions (3)
CL Item
>500 lesions (4)
Item Group
Parotid / Salivary gland swelling events (day 0-day 42)
C0240925 (UMLS CUI-1)
C0240668 (UMLS CUI-2)
Parotid Swelling number
Item
Parotid swelling No.
integer
C0240668 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Start date of parotid swelling
Item
Date started
date
C0240668 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date of parotid swelling
Item
Date stopped
date
C0240668 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
integer
C0240668 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of parotid swelling
Code List
Intensity
CL Item
Swelling without difficulties to move the jaw. (1)
CL Item
Swelling with difficulties to move the jaw. (2)
CL Item
Swelling and additional general symptoms. (3)
Item Group
Convulsion
C4048158 (UMLS CUI-1)
Convulsion number
Item
Convulsion No.
integer
C4048158 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Start date and time of febrile convulsion
Item
Date and Time started
datetime
C4048158 (UMLS CUI [1,1])
C2826806 (UMLS CUI [1,2])
End date and time of febrile convulsion
Item
Date and Time stopped
datetime
C4048158 (UMLS CUI [1,1])
C2826793 (UMLS CUI [1,2])
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item Group
Unsolicited symptoms (day 0 - day 42)
C1457887 (UMLS CUI-1)
C4055646 (UMLS CUI-2)
Description of unsolicited symptom
Item
Description - please specify side(s) and site(s)
text
C1457887 (UMLS CUI [1,1])
C4055646 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item
Intensity
integer
C0234687 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
Intensity of unsolicited symptom
Code List
Intensity
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal every day activities. (2)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal every day activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice) (3)
Start date of unsolicited event
Item
Start Date
date
C1457887 (UMLS CUI [1,1])
C4055646 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
End Date of unsolicited event
Item
End Date
date
C1457887 (UMLS CUI [1,1])
C4055646 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Unsolicited symptom continuing
Item
Unsolicited symptom is continuing
boolean
C1457887 (UMLS CUI [1,1])
C4055646 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item Group
Medication (day 0 - day 42)
C0013227 (UMLS CUI-1)
Trade name of medication
Item
Trade / Generic name
text
C0592503 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical indication for medication
Item
Reason
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of Medication
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuing
Item
Continuous medication
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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