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Informações:
Falhas:
ID
29478
Descrição
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
Palavras-chave
Versões (3)
- 31/03/2018 31/03/2018 -
- 04/04/2018 04/04/2018 -
- 04/04/2018 04/04/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
31 de março de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study 103792
Solicited Adverse Events after Dose 1 and 2
- StudyEvent: ODM
Similar models
Solicited Adverse Events after Dose 1 and 2
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject No
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Solicited adverse events - General symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
integer
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Code List
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
CL Item
Information not available (U)
(Comment:en)
CL Item
No vaccine administered (NA)
(Comment:en)
CL Item
Yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line. (Y)
(Comment:en)
CL Item
No (N)
(Comment:en)
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
CL Item
Temperature (FE)
CL Item
Irritability/Fussiness (IR)
CL Item
Loss of appetite (LO)
CL Item
Cough/runny nose (CO)
CL Item
Vomiting (VO)
CL Item
Diarrhea (DA)
Symptom present
Item
Symptom present
boolean
C1457887 (UMLS CUI [1])
symptom ongoing
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
date last 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])
C1386497 (UMLS CUI [1,2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Fever day and temperature
C0015967 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
C0439228 (UMLS CUI-2)
Fever temperature
Item
Fever temperature axillary
integer
C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Fever Day
Item
Fever Day (axillary)
integer
C0015967 (UMLS CUI [1])
Item Group
Irritability/Fussiness day and intensity
C0022107 (UMLS CUI-1)
C0522510 (UMLS CUI-2)
C0522510 (UMLS CUI-2)
Item
Irritability/Fussiness day
integer
C0022107 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
Item
Irritability/Fussiness intensity
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 Group
Cough/Runny nose day and intensity
C0010200 (UMLS CUI-1)
C0522510 (UMLS CUI-2)
C0522510 (UMLS CUI-2)
Cough/Runny nose day
Item
Cough/Runny nose day
integer
C0439228 (UMLS CUI [1,1])
C1260880 (UMLS CUI [1,2])
C1260880 (UMLS CUI [1,2])
Item
integer
C1260880 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0010200 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0522510 (UMLS CUI [1,2])
C0010200 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
CL Item
Normal (0)
CL Item
Cough/runny nose which is easily tolerated (1)
CL Item
Cough/runny nose which interferes with daily activity (2)
CL Item
Cough/runny nose which prevents daily activity (3)
Item Group
Loss of appetite day and intensity
C1971624 (UMLS CUI-1)
C0522510 (UMLS CUI-2)
C0522510 (UMLS CUI-2)
Loss of appetite day
Item
Loss of appetite day
integer
C0439228 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,2])
Item
Loss of appetite intensity
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
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 normalactivity (2)
CL Item
Not eating at all (3)
Vomiting day
Item
vomiting day
integer
C0042963 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
Vomiting Number of episodes
Item
Number of episodes
integer
C0042963 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
Vomiting day
Item
vomiting day
integer
C0042963 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
Vomiting Number of episodes
Item
Number of episodes
integer
C0042963 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
Stool samples
Item
Stool samples taken
boolean
C0015733 (UMLS CUI [1])
Stool collection time
Item
First stool collection day and time
datetime
C0015733 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
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])
C4064021 (UMLS CUI [1,2])
Item
Medication for diarrhea
text
C0011991 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
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)
Other medication for diarrhea
Item
Other medication:
text
C0011991 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])