Information:
Fel:
ID
25019
Beskrivning
Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A https://clinicaltrials.gov/ct2/show/NCT00291876
Länk
https://clinicaltrials.gov/ct2/show/NCT00291876
Nyckelord
Versioner (3)
- 2017-08-24 2017-08-24 -
- 2017-08-24 2017-08-24 -
- 2017-08-24 2017-08-24 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
24 augusti 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
Similar models
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Redness
Item
Redness, size
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 0
Item
Redness size day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 1
Item
Redness size day 1
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 2
Item
Redness size day 2
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 3
Item
Redness size day 3
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
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])
Size Swelling
Item
Size Swelling
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 0
Item
Size Swelling Day 0
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 1
Item
Size Swelling Day 1
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 2
Item
Size Swelling Day 2
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 3
Item
Size Swelling Day 3
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0038999 (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])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity
Item
Pain intensity
integer
C3840282 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (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])
C0030193 (UMLS CUI [1,2])
Description - please specify side(s) and site(s)
Item
Description - please specify side(s) and site(s)
text
C0441987 (UMLS CUI [1])
C1515974 (UMLS CUI [2])
C1515974 (UMLS CUI [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 spontaneously painful 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
Item
check box if continuing
boolean
C0549178 (UMLS CUI [1])
Trade / Generic Name
Item
Trade / Generic Name
text
C0027365 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Medical Indication
Item
Reason
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
pharmacotherapy ongoing
Item
check box if continuing
boolean
C0013216 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C1556354 (UMLS CUI [1])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
No [N] (1)
CL Item
Information not retrievable [U] (2)
CL Item
No vaccine administered [NA] (3)
CL Item
Yes [Y] (4)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
CL Item
Oral (recommended) (1)
CL Item
Axillary(recommended) (2)
CL Item
Rectal (3)
Fever Day 0
Item
Fever Day 0
float
C0015967 (UMLS CUI [1])
Fever Day 1
Item
Fever Day 1
float
C0015967 (UMLS CUI [1])
Fever Day 2
Item
Fever Day 2
float
C0015967 (UMLS CUI [1])
Fever Day 3
Item
Fever Day 3
float
C0015967 (UMLS CUI [1])
symptom ongoing
Item
Ongoing after day 3?
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])
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Fatigue ongoing after day 3
Item
Ongoing after day 3?
boolean
C0015672 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0015672 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Code List
Headache, Intensity
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Headache ongoing after day 3
Item
Headache ongoing after day 3?
boolean
C0018681 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms, Intensity
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
Code List
Gastrointestinal symptoms, Intensity
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Item
Gastrointestinal symptoms on Day 0
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 0
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Item
Gastrointestinal symptoms on Day 1
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 1
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Item
Gastrointestinal symptoms on Day 2
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 2
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Item
Gastrointestinal symptoms on Day 3
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 3
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Gastrointestinal symptoms ongoing after day 3
Item
Gastrointestinal symptoms ongoing after day 3?
boolean
C0426576 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0426576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
visit date
Item
PLEASE DO NOT FORGET TO BRING BACK THE DIARY CARD ON
date
C1320303 (UMLS CUI [1])
telephone number
Item
IN CASE OF HOSPITALISATION, PLEASE INFORM
text
C1515258 (UMLS CUI [1])
symptom
Item
Description - please specify side(s) and site(s)
text
C1457887 (UMLS CUI [1])
Intensity
Item
Intensity
integer
C0518690 (UMLS CUI [1])
symptom Start Date
Item
Start date:
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
ongoing
Item
check box if continuing
date
C0549178 (UMLS CUI [1])