ID

34933

Description

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. 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

Keywords

Versions (6)
  1. 2/4/19 2/4/19 -
  2. 2/7/19 2/7/19 -
  3. 2/10/19 2/10/19 -
  4. 2/12/19 2/12/19 -
  5. 2/16/19 2/16/19 -
  6. 2/20/19 2/20/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

February 4, 2019

DOI

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License

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

English

Solicited Adverse Events

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Solicited Adverse Events
Description

Solicited Adverse Events

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

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.

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
Solicited Adverse Events Record - Local Symptoms
Description

Solicited Adverse Events Record - Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Local Symptoms
Description

If redness, swelling or ecchymosis is ticked, provide size in mm. If pain is ticked, provide intensity from 0-3.

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Day 0
Description

Provide size/intensity of pain

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 1
Description

Provide size/intensity of pain

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 2
Description

Provide size/intensity of pain

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 3
Description

Provide size/intensity of pain

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 4
Description

Provide size/intensity of pain

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 5
Description

Provide size/intensity of pain

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Day 6
Description

Provide size/intensity of pain

Data type

integer

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0522510
UMLS CUI [3]
C2826182
Ongoing after Day 6?
Description

Ongoing Symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Description

Date of Last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
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 signs/symptoms during the solicited period?
Description

If yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items.

Data type

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
Solicited Adverse Events Record - General Symptoms
Description

Solicited Adverse Events Record - General Symptoms

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

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. arthralgia = joint pain

Data type

text

Alias
UMLS CUI [1]
C0159028
Day 0
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 1
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 2
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 3
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 4
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 5
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 6
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Ongoing after Day 6?
Description

Ongoing Symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Description

Date of Last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
Solicited Adverse Events - Fever
Description

Solicited Adverse Events - Fever

Fever
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Fever Measurement Route
Description

If fever is ticked

Data type

text

Alias
UMLS CUI [1,1]
C0449687
UMLS CUI [1,2]
C0015967
Day 0
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 1
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 2
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 3
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 4
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 5
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Day 6
Description

Provide intensity of fatigue, headache, musle ach, shivering or arthralgia

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826182
Ongoing after Day 6?
Description

Ongoing Symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of Last Day of Symptoms
Description

Date of Last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1]
C0015127
Unsolicited Adverse Events
Description

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events from Visit 1 to Visit 2?
Description

If yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report, as appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
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Similar models

Solicited Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Solicited Adverse Events
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Solicited Adverse Events
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Solicited Adverse Events Record - Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Local Symptoms
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local Symptoms
Code List
Local Symptoms
CL Item
Redness (RE)
CL Item
Swelling (SW)
CL Item
Ecchymosis (EC)
CL Item
Pain (PA)
Day 0
Item
Day 0
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 1
Item
Day 1
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 2
Item
Day 2
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 3
Item
Day 3
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 4
Item
Day 4
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 5
Item
Day 5
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Day 6
Item
Day 6
integer
C0456389 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C2826182 (UMLS CUI [3])
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
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 signs/symptoms during the solicited period?
text
C0159028 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Solicited Adverse Events - General Symptoms
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Solicited Adverse Events Record - General Symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
General Symptom
text
C0159028 (UMLS CUI [1])
General Symptom
Code List
General Symptom
CL Item
Fatigue (FA)
CL Item
Headache (HE)
CL Item
Muscle Ache (MH)
CL Item
Shivering (SH)
CL Item
Arthralgia (AR)
Day 0
Item
Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 1
Item
Day 1
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 2
Item
Day 2
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 3
Item
Day 3
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 4
Item
Day 4
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 5
Item
Day 5
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 6
Item
Day 6
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Item Group
Solicited Adverse Events - Fever
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Fever Measurement Route
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever Measurement Route
Code List
Fever Measurement Route
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Day 0
Item
Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 1
Item
Day 1
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 2
Item
Day 2
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 3
Item
Day 3
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 4
Item
Day 4
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 5
Item
Day 5
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Day 6
Item
Day 6
integer
C0518690 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
Ongoing Symptom
Item
Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of Last Day of Symptoms
Item
Date of Last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events from Visit 1 to Visit 2?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Unsolicited Adverse Events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events from Visit 1 to Visit 2?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
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