ID

36610

Beskrivning

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Nyckelord

Versioner (1)
  1. 2019-05-26 2019-05-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 maj 2019

DOI

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Creative Commons BY-NC 3.0
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DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

Engelsk

Diary Card - Dose 1

1 Formulär  
  1. StudyEvent: ODM
    1. Diary Card - Dose 1
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Solicited Adverse Events - Local Symptoms
Beskrivning

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Local Symptoms
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 0
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 1
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 2
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 3
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Ongoing after Day 3
Beskrivning

Adverse Event, Symptoms, Local, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0549178
Date of last Day of Symptoms
Beskrivning

Adverse Event, Symptoms, Local, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0806020
Medically attended visit
Beskrivning

Adverse Event, Symptoms, Local, Visit/Advice

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0545082
Other Local Symptoms
Beskrivning

Other Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0205394
Description - please specify side(s) and site(s)
Beskrivning

Symptoms, Local, Other

Datatyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
Intensity
Beskrivning

Symptoms, Local, Other, Symptom Intensity

Datatyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0518690
Start date
Beskrivning

Symptoms, Local, Other, Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0808070
End date
Beskrivning

Symptoms, Local, Other, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0806020
Check box if continuing
Beskrivning

Symptoms, Local, Other, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0549178
Medically attended Visit?
Beskrivning

Symptoms, Local, Other, Visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C020539
UMLS CUI [1,4]
C0545082
Solicited Adverse Events - General Symptoms
Beskrivning

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
General Symptoms
Beskrivning

Adverse Event, General symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 0
Beskrivning

Adverse Event, General symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 1
Beskrivning

Adverse Event, General symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 2
Beskrivning

Adverse Event, General symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 3
Beskrivning

Adverse Event, General symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Ongoing after Day 3
Beskrivning

Adverse Event, General symptom, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0549178
Date of last Day of Symptoms
Beskrivning

Adverse Event, General symptom, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0806020
Medically attended visit
Beskrivning

Adverse Event, General symptom, Visit/Advice

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0545082
Other General Symptoms
Beskrivning

Other General Symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0205394
Description - please give details below
Beskrivning

General symptom, Other

Datatyp

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
Intensity
Beskrivning

General symptom, Other, Symptom Intensity

Datatyp

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0518690
Start date
Beskrivning

General symptom, Other, Start date

Datatyp

date

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0808070
End date
Beskrivning

General symptom, Other, End date

Datatyp

date

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0806020
Check box if continuing
Beskrivning

General symptom, Other, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0549178
Medically attended Visit?
Beskrivning

General symptom, Other, Visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0545082
Medication
Beskrivning

Medication

Alias
UMLS CUI-1
C0013227
Trade/Generic name
Beskrivning

Pharmaceutical Preparations, Medication name

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Reason
Beskrivning

Pharmaceutical Preparations, Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Total Daily Dose
Beskrivning

Pharmaceutical Preparations, Daily Dose, Total

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Start date
Beskrivning

Pharmaceutical Preparations, Start date

Datatyp

date

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

Pharmaceutical Preparations, End date

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Check box if continuing
Beskrivning

Pharmaceutical Preparations, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Tillbaka till toppen

Similar models

Diary Card - Dose 1

1 Formulär
  1. StudyEvent: ODM
    1. Diary Card - Dose 1
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Local Symptoms
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Adverse Event, Symptoms, Local
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Item Group
Other Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Symptoms, Local, Other
Item
Description - please specify side(s) and site(s)
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Symptoms, Local, Other, Symptom Intensity
Item
Intensity
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,4])
Symptoms, Local, Other, Start Date
Item
Start date
date
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Symptoms, Local, Other, End Date
Item
End date
date
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Symptoms, Local, Other, Continuous
Item
Check box if continuing
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Symptoms, Local, Other, Visit
Item
Medically attended Visit?
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C020539 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
General Symptoms
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, Symptoms, Local
Code List
General Symptoms
CL Item
Temperature, give °C (1)
CL Item
Temperature: Axillary, Oral or Rectal (2)
CL Item
Irritability/Fussiness, give intensity (3)
CL Item
Drowsiness, give intensity (4)
CL Item
Loss of appetite, give intensity (5)
Adverse Event, General symptom
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Adverse Event, General symptom, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Adverse Event, General symptom, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item Group
Other General Symptoms
C0159028 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
General symptom, Other
Item
Description - please give details below
text
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
General symptom, Other, Symptom Intensity
Item
Intensity
text
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
General symptom, Other, Start date
Item
Start date
date
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
General symptom, Other, End date
Item
End date
date
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
General symptom, Other, Continuous
Item
Check box if continuing
boolean
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
General symptom, Other, Visit
Item
Medically attended Visit?
boolean
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item Group
Medication
C0013227 (UMLS CUI-1)
Pharmaceutical Preparations, Medication name
Item
Trade/Generic name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Pharmaceutical Preparations, Indication
Item
Reason
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pharmaceutical Preparations, Daily Dose, Total
Item
Total Daily Dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical Preparations, Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparations, End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Check box if continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Tillbaka till toppen 

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