ID
35022
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 his form is to document if the subject has had any adverse events in the course of the study. It should be filled out at the date of vaccination. SERIOUS ADVERSE EVENT A serious adverse event is any untoward medical occurrence that: · results in death · is life threatening · results in persistent or significant disability / incapacity · requires in-patient hospitalization · prolongation of existing hospitalization · is a congenital anomaly / birth defect in the offspring of a study subject · In addition, important medical events that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above should be considered serious. (Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization.) For each serious adverse event the investigator becomes aware of, please fill in a Serious Adverse Event(SAE) report and fax it to GSK Biologicals Study Contact for SAE reporting within 24 hours. 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 (6)
- 04.02.19 04.02.19 -
- 07.02.19 07.02.19 -
- 10.02.19 10.02.19 -
- 12.02.19 12.02.19 -
- 16.02.19 16.02.19 -
- 20.02.19 20.02.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
10. 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
Solicited Adverse Events
- StudyEvent: ODM
Beschreibung
Solicited Adverse Events
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beschreibung
If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report and fax to GSK Biologicals Study Contact for SAE reporting within 24 hours. If "yes" is ticked, please tick No/Yes for each symptom. If Yes is ticked, please complete all items.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0877248
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
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datentyp
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschreibung
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datentyp
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschreibung
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datentyp
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschreibung
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datentyp
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschreibung
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datentyp
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschreibung
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datentyp
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
Beschreibung
Provide size/intensity of pain Size in mm, if redness, swelling or ecchymosis is ticked Intensity: 0 / 1 / 2 / 3, if pain is ticked
Datentyp
integer
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2,1]
- C0030193
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3]
- C2826182
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
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
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
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
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
Causality
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015127
Beschreibung
Solicited Adverse Events - Fever
Beschreibung
Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C
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
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Day 0 not taken
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Day 1 not taken
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Day 2 not taken
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Day 3 not taken
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Day 4 not taken
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Day 5 not taken
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
Beschreibung
Provide intensity of fatigue, headache, musle ach, shivering or arthralgia
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826182
Beschreibung
Day 6 not taken
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0437722
- UMLS CUI [1,2]
- C2826182
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
Causality
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015127
Beschreibung
Unsolicited Adverse Events
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0042196
Ähnliche Modelle
Solicited Adverse Events
- StudyEvent: ODM
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C2745955 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
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])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI [1,2])