ID
35048
Beschreibung
Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of this document is to serve as a diary card for the subject. It should be filled out all through the study. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1
Link
https://clinicaltrials.gov/ct2/show/NCT00321373
Stichworte
Versionen (3)
- 12.02.19 12.02.19 -
- 16.02.19 16.02.19 -
- 22.02.19 22.02.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
12. Februar 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373
Diary Card
- StudyEvent: ODM
Beschreibung
Solicited Adverse Events Record - Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Beschreibung
Local Symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beschreibung
Symptom Occurrence
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2745955
Beschreibung
Study Day
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826182
Beschreibung
Intensity: Pain (at injection site): 0:Absent. 1:Painful on touch. 2:Painful when limb is moved. 3:Spontaneously painful / prevents normal activity.
Datentyp
integer
Beschreibung
Please measure the greatest diameter (in mm), if redness, swelling or ecchymosis is ticked
Datentyp
integer
Maßeinheiten
- mm
Beschreibung
Ongoing Symptom
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschreibung
if ongoing after Day 6
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschreibung
Other Local Symptoms (Day 0 to Day 29)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Beschreibung
please specify side(s) and site(s
Datentyp
text
Alias
- UMLS CUI [1]
- C0678257
Beschreibung
Other local symptoms: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy).
Datentyp
integer
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
tick box if continuing
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschreibung
Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Trade/Generic Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
Beschreibung
Reason
Datentyp
text
Alias
- UMLS CUI [1]
- C0392360
Beschreibung
Total Daily Dose
Datentyp
text
Alias
- UMLS CUI [1]
- C2348070
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
tick box if continuing
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschreibung
Solicited Adverse Events Record - General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beschreibung
arthralgia = joint pain
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C1556354
Beschreibung
Symptom Occurrence
Datentyp
boolean
Beschreibung
Study Day
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826182
Beschreibung
Fatigue, Headache, Muscle Ache, Shivering, Arthralgia/Joint Pain 0: Normal 1: Easily tolerated 2: Interferes with normal activity 3: That prevents normal activity
Datentyp
integer
Beschreibung
Ongoing Symptom
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschreibung
Date of Last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschreibung
Solicited Adverse Events - Fever
Beschreibung
Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C Temperature: Please record the temperature every day in the evening. Should additional temperature measurements be performed at other times of the day, the highest temperature is to be recorded.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschreibung
If fever is ticked oral is preferred
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Beschreibung
Study Day
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826182
Beschreibung
Body Temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Ongoing Symptom
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschreibung
Date of Last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschreibung
Other General Symptoms (Day 0 to Day 29)
Alias
- UMLS CUI-1
- C0029625
Beschreibung
please specify side(s) and site(s
Datentyp
text
Alias
- UMLS CUI [1]
- C0678257
Beschreibung
Other local symptoms: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy).
Datentyp
integer
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
tick box if continuing
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Ähnliche Modelle
Diary Card
- StudyEvent: ODM
C0042196 (UMLS CUI [1,2])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C2745955 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0159028 (UMLS CUI [1,2])
C1556354 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0015967 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])