ID

29492

Description

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

Keywords

Versions (3)
  1. 3/31/18 3/31/18 -
  2. 4/4/18 4/4/18 -
  3. 4/4/18 4/4/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 4, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study NCT00289172

English

Solicited Adverse Events after Dose 1 and 2

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject No

Data type

integer

Alias
UMLS CUI [1]
C2348585
Solicited adverse events - General symptoms
Description

Solicited adverse events - General symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
Description

General symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
General Symptoms
Description

General Symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Symptom
Description

Symptom

Data type

text

Alias
UMLS CUI [1]
C1457887
Symptom present
Description

Symptom present

Data type

boolean

Alias
UMLS CUI [1]
C1457887
Ongoing after day 7?
Description

symptom ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of last day of symptoms
Description

date last symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Medically attended visit Type
Description

Medically attended visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
Fever day and temperature
Description

Fever day and temperature

Alias
UMLS CUI-1
C0015967
UMLS CUI-2
C0439228
Fever temperature axillary
Description

Fever temperature

Data type

integer

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0015967
°C
Fever Day (axillary)
Description

Fever Day

Data type

integer

Measurement units
  • Day
Alias
UMLS CUI [1]
C0015967
Day
Irritability/Fussiness day and intensity
Description

Irritability/Fussiness day and intensity

Alias
UMLS CUI-1
C0022107
UMLS CUI-2
C0522510
Irritability/Fussiness day
Description

Irritability/Fussiness day

Data type

integer

Measurement units
  • Day
Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0439228
Irritability/Fussiness intensity
Description

Irritability/Fussiness intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Cough/Runny nose day and intensity
Description

Cough/Runny nose day and intensity

Alias
UMLS CUI-1
C0010200
UMLS CUI-2
C0522510
Cough/Runny nose day
Description

Cough/Runny nose day

Data type

integer

Measurement units
  • Day
Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1260880
Day
Cough/Runny nose intensity
Description

Cough/Runny nose intensity

Data type

integer

Alias
UMLS CUI [1,1]
C1260880
UMLS CUI [1,2]
C0522510
UMLS CUI [2,1]
C0010200
UMLS CUI [2,2]
C0522510
Loss of appetite day and intensity
Description

Loss of appetite day and intensity

Alias
UMLS CUI-1
C1971624
UMLS CUI-2
C0522510
Loss of appetite day
Description

Loss of appetite day

Data type

integer

Measurement units
  • Day
Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1971624
Day
Loss of appetite intensity
Description

Loss of appetite intensity

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Vomiting day and episodes
Description

Vomiting day and episodes

Alias
UMLS CUI-1
C0042963
vomiting day
Description

Vomiting day

Data type

integer

Measurement units
  • Day
Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0439228
Day
Number of episodes
Description

Vomiting Number of episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C4086638
Diarrhea day end episodes
Description

Diarrhea day end episodes

vomiting day
Description

Vomiting day

Data type

integer

Measurement units
  • Day
Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0439228
Day
Number of episodes
Description

Vomiting Number of episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C4086638
Diarrhea
Description

Diarrhea

Alias
UMLS CUI-1
C0011991
Stool samples taken
Description

One single stool sample should be collected as soon as possible and not later than 7 days after the beginning of the diarrhea. A second stool sample can be taken if the first one is insufficient

Data type

boolean

Alias
UMLS CUI [1]
C0015733
First stool collection day and time
Description

Stool collection time

Data type

datetime

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

Stool collection time

Data type

datetime

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

Medication for diarrhea

Data type

text

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0087111
Other medication:
Description

Other medication for diarrhea

Data type

text

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0087111
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Similar models

Solicited Adverse Events after Dose 1 and 2

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
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)
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])
General symptoms
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)
Item
Symptom
text
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
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])
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])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
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])
Medical advice Type
Code List
Medically attended visit Type
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)
Fever temperature
Item
Fever temperature axillary
integer
C0039476 (UMLS CUI [1,1])
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)
Item
Irritability/Fussiness day
integer
C0022107 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Irritability/Fussiness day
Code List
Irritability/Fussiness day
Item
Irritability/Fussiness intensity
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Irritability/Fussiness intensity
Code List
Irritability/Fussiness intensity
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)
Cough/Runny nose day
Item
Cough/Runny nose day
integer
C0439228 (UMLS CUI [1,1])
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])
Cough/Runny nose intensity
Code List
Cough/Runny nose intensity
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)
Loss of appetite day
Item
Loss of appetite day
integer
C0439228 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Item
Loss of appetite intensity
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite intensity
Code List
Loss of appetite intensity
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)
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
Diarrhea day end episodes
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
Diarrhea
C0011991 (UMLS CUI-1)
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])
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)
Other medication for diarrhea
Item
Other medication:
text
C0011991 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
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