ID

32103

Beskrivning

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains report of solicited adverse events for local and general symptoms. It has to be filled in for workbook 1 and 2 in visit 1,2,3 and 6. It refers only to immuno and reacto subset.

Nyckelord

Versioner (4)
  1. 10/17/18 10/17/18 -
  2. 10/18/18 10/18/18 - Sarah Riepenhausen
  3. 10/23/18 10/23/18 -
  4. 10/26/18 10/26/18 -
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GlaxoSmithKline

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October 17, 2018

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Vaccination against pneumonia and otitis media 109563, NCT00466947

Engelsk

Solicited adverse events - local and general symptoms

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit number
Beskrivning

Visit number

Datatyp

integer

Alias
UMLS CUI [1]
C1549755
Workbook number
Beskrivning

Workbook number

Datatyp

integer

Alias
UMLS CUI [1]
C2986015
Solicited adverse events. local symptoms.
Beskrivning

Solicited adverse events. local symptoms.

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Vaccination
Beskrivning

Please fill in this itemgroup for both vaccinations

Datatyp

integer

Alias
UMLS CUI [1]
C0042196
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beskrivning

Vaccination signs/symptoms

Datatyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0042196
Local symptoms
Beskrivning

Please fill in the following items for each symptom observed, if applicable.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Day
Beskrivning

Please fill in item Size or Intensity for each day (whichever applicable).

Datatyp

integer

Alias
UMLS CUI [1]
C0439228
If local symptoms confirmed please note the size
Beskrivning

only if Redness or Swelling. 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.

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1]
C0456389
mm
Intensity of pain
Beskrivning

only if Pain. 0: Absent 1: Minor reaction to touch 2: Cries / protests on touch 3: Cries when limb is moved / spontaneously painful

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
Ongoing after day 3
Beskrivning

Ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1]
C0549178
If ongoing, date of last day of symptoms
Beskrivning

Date, if ongoing

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Medically attended visit
Beskrivning

Medically attended

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Type of medically attended visit
Beskrivning

Type of medically attended visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332307
Solicited adverse events. General symptoms.
Beskrivning

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?
Beskrivning

Vaccination general symptoms

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1457887
General symptoms
Beskrivning

Please fill in the following item for each symptom observed, if applicable. Fever is defined as: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C Tympanic (oral conversion) > 37.5°C Tympanic (rectal conversion) > 38° C

Datatyp

text

Alias
UMLS CUI [1]
C0159028
Day of general symptom
Beskrivning

Please fill in Temperature Measurement (or not taken; Fever) or Intensity (other general symptoms) for each day

Datatyp

integer

Alias
UMLS CUI [1]
C0439228
If fever, please note measurement location
Beskrivning

Location of Temperature Measurement

Datatyp

text

Alias
UMLS CUI [1,1]
C0449687
UMLS CUI [1,2]
C0005903
I fever note temperature measurement
Beskrivning

Temperature measurement

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
If fever, why is temperature not taken
Beskrivning

Temperature not taken

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1272460
Intensity of Irritability / fussiness
Beskrivning

0: Behavior as usual 1: Crying more than usual / no effect on normal activity 2: Crying more than usual / interferes with normal activity 3: Crying that cannot be comforted / prevents normal activity

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0022107
Intensity of Drowsiness
Beskrivning

0: Behavior as usual 1: Drowsiness easily tolerated 2: Drowsiness that interferes with normal activity 3: Drowsiness that prevents normal activity

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0013144
Intensity of Loss of appetite
Beskrivning

0: Appetite as usual 1: Eating less than usual / no effect on normal activity 2: Eating less than usual / interferes with normal activity 3: Not eating at all

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1971624
Ongoing of fever/symptoms after Day 3
Beskrivning

Ongoing after Day 3

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0015967
UMLS CUI [2,1]
C0549178
UMLS CUI [2,2]
C0159028
If ongoing, date of last Day of symptoms
Beskrivning

Date, if ongoing

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Causality
Beskrivning

Is there a reasonable possibility that the AE may have been caused by the investigational product? NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event.

Datatyp

boolean

Alias
UMLS CUI [1]
C0015127
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Type of medically attended visit
Beskrivning

Type of medically attended visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332307
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Similar models

Solicited adverse events - local and general symptoms

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 6 (6)
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
workbook 1  (1)
CL Item
workbook 2 (2)
Item Group
Solicited adverse events. local symptoms.
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Vaccination
integer
C0042196 (UMLS CUI [1])
Vaccination
Code List
Vaccination
CL Item
10Pn-PD-DiT or HBV Vaccine (1)
CL Item
Infanrix Hexa or DTPa-IPV/Hib Vaccine (2)
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Vaccination signs/symptoms
Code List
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
No  (N)
CL Item
Information not available  (U)
CL Item
No vaccine administered (NA)
CL Item
Yes (Y)
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptoms
Code List
Local symptoms
CL Item
Redness (1)
CL Item
Swelling  (2)
CL Item
Pain (3)
Item
Day
integer
C0439228 (UMLS CUI [1])
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Size
Item
If local symptoms confirmed please note the size
float
C0456389 (UMLS CUI [1])
Item
Intensity of pain
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Intensity at day
Code List
Intensity of pain
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing after day 3
Item
Ongoing after day 3
boolean
C0549178 (UMLS CUI [1])
Date, if ongoing
Item
If ongoing, date of last day of symptoms
date
C0011008 (UMLS CUI [1])
Medically attended
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item
Type of medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of medically attended visit
Code List
Type of medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
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
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Vaccination symptoms
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
No  (N)
CL Item
Information not available  (U)
CL Item
No vaccine administered (NA)
CL Item
Yes (Y)
Item
General symptoms
text
C0159028 (UMLS CUI [1])
General symptoms
Code List
General symptoms
CL Item
Fever  (FE)
CL Item
Irritability/Fussiness (IR)
CL Item
Drowsiness (DR)
CL Item
Loss of (LO)
CL Item
appetite (appetite)
Item
Day of general symptom
integer
C0439228 (UMLS CUI [1])
Day
Code List
Day of general symptom
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
If fever, please note measurement location
text
C0449687 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])
Fever developed
Code List
If fever, please note measurement location
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
CL Item
Tympanic oral (X)
CL Item
Tympanic rectal (Y)
Temperature measurement
Item
I fever note temperature measurement
float
C0005903 (UMLS CUI [1])
Temperature not taken
Item
If fever, why is temperature not taken
boolean
C0005903 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
Item
Intensity of Irritability / fussiness
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Intensity: Irritability / fussiness
Code List
Intensity of Irritability / fussiness
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
0 (0)
Item
Intensity of Drowsiness
integer
C0518690 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Intensity: Drowsiness
Code List
Intensity of Drowsiness
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
0 (0)
Item
Intensity of Loss of appetite
integer
C0518690 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Intensity: Loss of appetite
Code List
Intensity of Loss of appetite
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
0 (0)
Ongoing after Day 3
Item
Ongoing of fever/symptoms after Day 3
boolean
C0549178 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0549178 (UMLS CUI [2,1])
C0159028 (UMLS CUI [2,2])
Date, if ongoing
Item
If ongoing, date of last Day of symptoms
date
C0011008 (UMLS CUI [1])
Causality
Item
Causality
boolean
C0015127 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item
Type of medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
undefined item
Code List
Type of medically attended visit
CL Item
Hospitalization  (HO)
CL Item
Emergency Room  (ER)
CL Item
Medical Personnel (MD)
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