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24688
Beschreibung
Study ID: 100478 Clinical Study ID: 100478 Study Title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290303 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis This form contains the Diary Card
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Versionen (1)
- 13.08.17 13.08.17 -
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GlaxoSmithKline
Hochgeladen am
13. August 2017
DOI
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Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B Diary Card NCT00290303
GSK non-inferiority of Tritanrix Hepatitis B Diary Card NCT00290303
Ähnliche Modelle
GSK non-inferiority of Tritanrix Hepatitis B Diary Card NCT00290303
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Redness size
Item
Redness size
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
Redness Day 0
Item
Redness Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
Redness Day 1
Item
Redness Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
Redness Day 2
Item
Redness Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
Redness Day 3
Item
Redness Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (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])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended Visit?
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling Day 0
Item
Swelling Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling Day 1
Item
Swelling Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling Day 2
Item
Swelling Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling Day 3
Item
Swelling Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (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])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Item
Pain intensity day 0
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Item
Pain intensity day 1
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Item
Pain intensity day 2
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Item
Pain intensity day 3
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
CL Item
0 Absent (1)
CL Item
1 Minor reaction to touch (2)
CL Item
2 Cries/protests on touch (3)
CL Item
3 Cries when limb is moved /spontaneously painful (4)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0426576 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0426576 (UMLS CUI [1,4])
CL Item
Emergency room (ER)
CL Item
Hospitalization (HO)
CL Item
Medical doctor (MD)
Other local symptoms
Item
Other local symptoms
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Other local symptoms Description
Item
Other local symptoms Description
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Item
Other local symptoms Description
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
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 everyday 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 or kindergarten or a day care center and would cause the parents or guardians to seek medical advice. (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
End date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Adverse Event Ongoing
Item
Ongoing?
boolean
C2826663 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
start date
Item
Day 0
date
C0808070 (UMLS CUI [1])
Temperature (Evening)
Item
Temperature (Evening)
boolean
C0005903 (UMLS CUI [1])
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Temperature Day 0
Item
Temperature Day 0
integer
C0005903 (UMLS CUI [1])
Temperature Day 1
Item
Temperature Day 1
integer
C0005903 (UMLS CUI [1])
Temperature Day 2
Item
Temperature Day 2
integer
C0005903 (UMLS CUI [1])
Temperature Day 3
Item
Temperature Day 3
integer
C0005903 (UMLS CUI [1])
Temperature
Item
Temperature Ongoing after Day 3?
boolean
C0005903 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Irritability/Fussiness
Item
Irritability/Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability Fussiness Intensity Day 0
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual no effect on normal activity (1)
CL Item
Crying more than usual interferes with normal activity (2)
CL Item
Crying that cannot be comforted prevents normal activity (3)
Item
Irritability Fussiness Intensity Day 1
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual no effect on normal activity (1)
CL Item
Crying more than usual interferes with normal activity (2)
CL Item
Crying that cannot be comforted prevents normal activity (3)
Item
Irritability Fussiness Intensity Day 2
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual no effect on normal activity (1)
CL Item
Crying more than usual interferes with normal activity (2)
CL Item
Crying that cannot be comforted prevents normal activity (3)
Item
Irritability Fussiness Intensity Day 3
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual no effect on normal activity (1)
CL Item
Crying more than usual interferes with normal activity (2)
CL Item
Crying that cannot be comforted prevents normal activity (3)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual no effect on normal activity (1)
CL Item
Eating less than usual interferes with normal activity (2)
CL Item
Not eating at all (3)
CL Item
Appetite as usual (0)
CL Item
Eating less than usual no effect on normal activity (1)
CL Item
Eating less than usual interferes with normal activity (2)
CL Item
Not eating at all (3)
CL Item
Appetite as usual (0)
CL Item
Eating less than usual no effect on normal activity (1)
CL Item
Eating less than usual interferes with normal activity (2)
CL Item
Not eating at all (3)
CL Item
Appetite as usual (0)
CL Item
Eating less than usual no effect on normal activity (1)
CL Item
Eating less than usual interferes with normal activity (2)
CL Item
Not eating at all (3)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Other general Symptoms
Item
Other general Symptoms
boolean
C1457887 (UMLS CUI [1])
Other general Symptoms
Item
Other general Symptoms
text
C1457887 (UMLS CUI [1])
Other general Symptoms
Item
Other general Symptoms
text
C1457887 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
Continuing?
Item
Continuing?
boolean
C0549178 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medication
Item
Medication
boolean
C0013227 (UMLS CUI [1])
Trade Generic name
Item
Trade Generic name
text
C0592502 (UMLS CUI [1])
Medication Reason
Item
Medication Reason
text
C0332307 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,3])
C0348080 (UMLS CUI [1,4])
C0030705 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,3])
C0348080 (UMLS CUI [1,4])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Continuing
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])