ID

29951

Beschreibung

A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Study ID:103792 Clinical Study ID:103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus CRF Seiten: 375-430

Stichworte

Versionen (1)
  1. 29.04.18 29.04.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

29. April 2018

DOI

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Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study NCT00289172

Deutsch Englisch

Diary Card Dose 1

1 Formulare  
  1. StudyEvent: ODM
    1. Diary Card Dose 1
Header
Beschreibung

Header

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Temperature
Beschreibung

Temperature

Alias
UMLS CUI-1
C0039476
Day
Beschreibung

Route: Axillary

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0039476
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • degree Celsius
Alias
UMLS CUI [1]
C0039476
degree Celsius
Temperature
Beschreibung

Temperature

Alias
UMLS CUI-1
C0005903
Fever ongoing after day 7?
Beschreibung

Ongoing fever

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0549178
Date of last day of symptoms of fever
Beschreibung

If you answered the previous question with yes, please specify

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015967
Medically attended visit concerning fever
Beschreibung

Medically attended visit concerning fever

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0015967
Irritability/Fussiness, Loss of appetite, Cough/runny nose daily intensities
Beschreibung

Irritability/Fussiness, Loss of appetite, Cough/runny nose daily intensities

Alias
UMLS CUI-1
C0022107
UMLS CUI-2
C0522510
UMLS CUI-3
C1260880
UMLS CUI-4
C0522510
UMLS CUI-5
C0010200
UMLS CUI-6
C1971624
UMLS CUI-7
C0522510
Symptom
Beschreibung

Symptom

Datentyp

text

Alias
UMLS CUI [1]
C1457887
Day of symptom
Beschreibung

Day of symptom

Datentyp

integer

Alias
UMLS CUI [1]
C0011008
Intensity
Beschreibung

Irritability/fussiness: 0: Behavior as usual 1: Crying more than usual / no effect on normal activity 2: Crying more than usual / interferes with normal activity 3: Crying that cannot be comforted / prevents normal activity Loss of appetite: 0: Appetite as usual 1: Eating less than usual / no effect on normal activity 2: Eating less than usual / interferes with normal activity 3: Not eating at al Cough/runny nose: 0: Normal 1: Cough/runny nose which is easily tolerated 2: Cough/runny nose which interferes with daily activity 3: Cough/runny nose which prevents daily activity

Datentyp

integer

Alias
SNOMEDCT_2012_01_31
103370009
UMLS CUI [1]
C0522510
Irritability/Fussiness, Loss of appetite, Cough/runny nose ongoing
Beschreibung

Irritability/Fussiness, Loss of appetite, Cough/runny nose ongoing

Alias
UMLS CUI-1
C0022107
UMLS CUI-2
C0522510
UMLS CUI-3
C1260880
UMLS CUI-4
C0522510
UMLS CUI-5
C0010200
UMLS CUI-6
C1971624
UMLS CUI-7
C0522510
Symptom
Beschreibung

Symptom

Datentyp

text

Alias
UMLS CUI [1]
C1457887
Symptom ongoing after day 7?
Beschreibung

Ongoing symptom

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Last date of symptom
Beschreibung

Last date of symptom

Datentyp

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0011008
Medically attended visit concerning symptom
Beschreibung

Medically attended visit concerning symptom

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1457887
Vomiting day and episodes
Beschreibung

Vomiting day and episodes

Alias
UMLS CUI-1
C0042963
vomiting day
Beschreibung

Vomiting day

Datentyp

integer

Maßeinheiten
  • Day
Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0439228
Day
Number of episodes
Beschreibung

Vomiting Number of episodes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C4086638
Vomiting ongoing
Beschreibung

Vomiting ongoing

Alias
UMLS CUI-1
C0042963
UMLS CUI-2
C0549178
Ongoing after day 7?
Beschreibung

vomiting ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0549178
Date of last day of vomiting
Beschreibung

date last vomiting

Datentyp

date

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Gastroenteritis Episodes
Beschreibung

Gastroenteritis Episodes

Alias
UMLS CUI-1
C0017160
Episode Number
Beschreibung

Gastroenteritis Episode

Datentyp

integer

Alias
UMLS CUI [1,1]
C0017160
UMLS CUI [1,2]
C0332189
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type - Medical advice
Beschreibung

Type - Medical advice

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
First stool collection day and time
Beschreibung

Stool collection time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0015733
UMLS CUI [1,2]
C4064021
Second stool collection day and time
Beschreibung

Stool collection time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0015733
UMLS CUI [1,2]
C4064021
Medication for diarrhea
Beschreibung

Medication for diarrhea

Datentyp

text

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0087111
Information diary card
Beschreibung

Information diary card

Alias
UMLS CUI-1
C3890583
Please do not forget to bring back the diary card on
Beschreibung

return date diary card

Datentyp

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
In case of hospitalization please inform (name):
Beschreibung

Hospitalisation information

Datentyp

text

Alias
UMLS CUI [1]
C0019993
In case of hospitalization please inform (TelNr):
Beschreibung

Telephone number

Datentyp

integer

Alias
UMLS CUI [1]
C1515258
Unsolicited symptoms
Beschreibung

Unsolicited symptoms

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

Description of unsolicited symptom

Datentyp

text

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

Intensity of unsolicited symptom

Datentyp

integer

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

Start date of unsolicited event

Datentyp

date

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

End Date of unsolicited event

Datentyp

date

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

Unsolicited symptom continuing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C4055646
UMLS CUI [1,3]
C0549178
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0087111
Trade or generic name
Beschreibung

Medication name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Beschreibung

Indication

Datentyp

text

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

Total daily dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Route
Beschreibung

Administration Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013227
End Date
Beschreibung

Medication End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013227
Medication Ongoing
Beschreibung

Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
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Ähnliche Modelle

Diary Card Dose 1

1 Formulare
  1. StudyEvent: ODM
    1. Diary Card Dose 1
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Temperature
C0039476 (UMLS CUI-1)
Day
Item
Day
integer
C0439228 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,3])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item Group
Temperature
C0005903 (UMLS CUI-1)
Ongoing fever
Item
Fever ongoing after day 7?
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Last date of fever
Item
Date of last day of symptoms of fever
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Medically attended visit concerning fever
Item
Medically attended visit concerning fever
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Item Group
Irritability/Fussiness, Loss of appetite, Cough/runny nose daily intensities
C0022107 (UMLS CUI-1)
C0522510 (UMLS CUI-2)
C1260880 (UMLS CUI-3)
C0522510 (UMLS CUI-4)
C0010200 (UMLS CUI-5)
C1971624 (UMLS CUI-6)
C0522510 (UMLS CUI-7)
Item
Symptom
text
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
CL Item
Irritability/Fussiness (1)
CL Item
Loss of appetite (2)
CL Item
Cough/runny nose (3)
Day of symptom
Item
Day of symptom
integer
C0011008 (UMLS CUI [1])
Intensity
Item
Intensity
integer
103370009 (SNOMEDCT_2012_01_31)
C0522510 (UMLS CUI [1])
Item Group
Irritability/Fussiness, Loss of appetite, Cough/runny nose ongoing
C0022107 (UMLS CUI-1)
C0522510 (UMLS CUI-2)
C1260880 (UMLS CUI-3)
C0522510 (UMLS CUI-4)
C0010200 (UMLS CUI-5)
C1971624 (UMLS CUI-6)
C0522510 (UMLS CUI-7)
Item
Symptom
text
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
CL Item
Irritability/Fussiness (1)
CL Item
Loss of appetite (2)
CL Item
Cough/runny nose (3)
Ongoing symptom
Item
Symptom ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Last date of symptom
Item
Last date of symptom
date
C1457887 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Medically attended visit concerning symptom
Item
Medically attended visit concerning symptom
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
Vomiting day and episodes
C0042963 (UMLS CUI-1)
Vomiting day
Item
vomiting day
integer
C0042963 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Vomiting Number of episodes
Item
Number of episodes
integer
C0042963 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item Group
Vomiting ongoing
C0042963 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
vomiting ongoing
Item
Ongoing after day 7?
boolean
C0042963 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
date last vomiting
Item
Date of last day of vomiting
date
C0042963 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (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])
Item Group
Gastroenteritis Episodes
C0017160 (UMLS CUI-1)
Gastroenteritis Episode
Item
Episode Number
integer
C0017160 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type - Medical advice
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical advice
Code List
Type - Medical advice
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Stool collection time
Item
First stool collection day and time
datetime
C0015733 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Stool collection time
Item
Second stool collection day and time
datetime
C0015733 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Item
Medication for diarrhea
text
C0011991 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Medication for diarrhea
Code List
Medication for diarrhea
CL Item
Oral rehydration (1)
CL Item
IV rehydration (2)
CL Item
Oral and IV rehydration (3)
CL Item
No medication (4)
CL Item
Other, please specify (5)
Item Group
Information diary card
C3890583 (UMLS CUI-1)
return date diary card
Item
Please do not forget to bring back the diary card on
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Hospitalisation information
Item
In case of hospitalization please inform (name):
text
C0019993 (UMLS CUI [1])
Telephone number
Item
In case of hospitalization please inform (TelNr):
integer
C1515258 (UMLS CUI [1])
Item Group
Unsolicited symptoms
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])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item Group
Medication
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Medication name
Item
Trade or generic name
text
C2360065 (UMLS CUI [1])
Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Administration Route
Code List
Route
Medication Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing
boolean
C2826666 (UMLS CUI [1])
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