Information:
Fel:
ID
32089
Beskrivning
Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is a diary card. To be filled in by the subject's parents/guardians after Dose 1 and 2 of the study vaccination (after Visits 3 and 5) and brought back for visit 4 and 6.
Länk
https://clinicaltrials.gov/ct2/show/NCT00139334
Nyckelord
Versioner (1)
- 2018-10-17 2018-10-17 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKlinie
Uppladdad den
17 oktober 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334
Similar models
Diary Card
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
CL Item
1 (1)
CL Item
2 (2)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Return date for diary card
Item
Please do not forget to bring back the diary card on...
date
C0011008 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
contact person
Item
In case of hospitalisation, please inform
text
C0337611 (UMLS CUI [1])
Telephone number of contact person
Item
In case of hospitalisation, please inform (Telephone)
integer
C1515258 (UMLS CUI [1,1])
C0337611 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,2])
CL Item
Day 0 (Day 0)
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 3 (Day 3)
CL Item
Day 4 (Day 4)
CL Item
Day 5 (Day 5)
CL Item
Day 6 (Day 6)
CL Item
Day 7 (Day 7)
Fever
Item
Fever
float
C0015967 (UMLS CUI [1])
Item
Intensity of irritability / fussiness
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
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)
CL Item
behavior as usual (0)
Item
Intensity of Loss of appetite
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
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)
Times of Vomiting
Item
Number of times of Vomiting per day
integer
C0042963 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Number of looser than normal stools
Item
Number of looser than normal stools per day
integer
C2129214 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,2])
Item Group
Solicited General Symptoms Specifications
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C1517001 (UMLS CUI-3)
C2348235 (UMLS CUI-4)
C1457887 (UMLS CUI-2)
C1517001 (UMLS CUI-3)
C2348235 (UMLS CUI-4)
CL Item
Axillary (A)
CL Item
Rectal (R)
Temperature Duration
Item
Temperature ongoing after day 7?
boolean
C0005903 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Date of last day of temperature
Item
If ongoing, Date of last day of temperature
date
C0005903 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Irritability / Fussiness Duration
Item
If Irritability / Fussiness (IR), ongoing after day 7?
boolean
C0022107 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Date of last day of Irritability / Fussiness
Item
If ongoing, Date of last day of Irritability / Fussiness (IR)
date
C0022107 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Loss of Appetite Duration
Item
If Loss of Appetite (LO), ongoing after day 7?
boolean
C1971624 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Date of last day of Loss of Appetite
Item
If ongoing, Date of last day of Loss of Appetite
date
C1971624 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Vomiting Duration
Item
If Vomiting (VO), ongoing after day 7?
boolean
C0042963 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
date of last day of Vomiting
Item
If ongoing, date of last day of Vomiting
date
C0042963 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Diarrhea Duration
Item
If Diarrhea (DA), ongoing after day 7?
boolean
C0011991 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Date of last day of Diarrhea
Item
If ongoing, Date of last day of Diarrhea (DA)
date
C0011991 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Stools samples
Item
Stools samples taken
boolean
C1550661 (UMLS CUI [1])
Date of stools samples
Item
If yes, Date
date
C0011008 (UMLS CUI [1,1])
C1550661 (UMLS CUI [1,2])
C1550661 (UMLS CUI [1,2])
Item Group
Medication: Please fill in if any medication has been taken in case of diarrhea episode.
C0013227 (UMLS CUI-1)
C0011991 (UMLS CUI-2)
C0011991 (UMLS CUI-2)
Trade/generic name
Item
Trade/generic name
text
C2360065 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing Medication
Item
Check box if ongoing.
boolean
C2826666 (UMLS CUI [1])
Diarrhea episode symptoms
Item
Diarrhea episode symptoms: Please give details
text
C0011991 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
Item
Diarrhea episode symptom intensity
integer
C0011991 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
normal (0)
CL Item
gastroenteritis episode which is easily tolerated by the subject, causing minimal discomfort and not interfering with everday activities. (1)
CL Item
Gastroenteritis episode which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Gastroenteritis episode 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
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing Diarrhea
Item
check box if continuing.
boolean
C0011991 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Stool sample date
Item
Please fill in below the date of any stool collection.
date
C1550661 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
Item Group
Gastroenteritis Medication
C0017160 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0013227 (UMLS CUI-2)
Medication name
Item
Medication name
text
C2360065 (UMLS CUI [1])
Total Daily dose
Item
Total Daily dose
text
C2348070 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing Gastroenteritis
Item
check box if continuing.
boolean
C0017160 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Symptom description
Item
Other general symptoms (excluding gastroenteritis episode), Description - please give details below.
text
C1457887 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. (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/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing symptoms
Item
Check box if continuing.
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Item Group
Other medication (excluding Gastroenteritis medication)
C0013227 (UMLS CUI-1)
Trade/generic name
Item
Trade/generic name
text
C2360065 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Ongoing Medication
Item
Check box, if continuing.
boolean
C2826666 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])