ID

34932

Beschrijving

Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus This form contains information about solicited adverse events and should be filled in at visit 1, 2 and 3. If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report. (Definition of serious: 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, requires prolongation of existing hospitalization, is a congenital anomaly / birth defect in the offspring of a study subject, is an important medical event that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above)

Link

https://clinicaltrials.gov/ct2/show/NCT00290277

Trefwoorden

Versies (1)
  1. 04-02-19 04-02-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

4 februari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277

Engels

Solicited adverse events

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Protocol number
Beschrijving

Protocol number

Datatype

text

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Visit number
Beschrijving

Visit number

Datatype

text

Alias
UMLS CUI [1]
C1549755
Date of visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Solicited adverse events - local symptoms
Beschrijving

Solicited adverse events - local symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
UMLS CUI-4
C0877248
UMLS CUI-5
C1517001
Has the subject experienced any of the following local signs/symptoms at the administration site during the solicited period?
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2700396
UMLS CUI [1,4]
C0042210
Details of local symptoms
Beschrijving

Details of local symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C2700396
UMLS CUI-4
C0042210
UMLS CUI-5
C1521902
UMLS CUI-6
C1517001
Experienced local symptoms
Beschrijving

Please tick experienced symptom(s) one after the other and specify symptoms below. Complete size (mm) in Occurence of Redness or Swelling. Complete intensity in occurrence of pain.

Datatype

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0441987
UMLS CUI [1,4]
C0042196
Local symptom: Day(s) of occurence
Beschrijving

Please fill in the day(s) of occurence one after the other with the associated size of redness/swelling (mm) respectively intensity of pain below.

Datatype

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0439228
UMLS CUI [1,5]
C0042196
Local symptom: size (mm)
Beschrijving

If redness or swelling occured, please specify the size with the associated day of occurence documented above.

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
UMLS CUI [1,4]
C0042210
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C2700396
UMLS CUI [2,4]
C0042210
mm
Local symptom: intensity
Beschrijving

This item has to be filled for local symptom pain. Please specify intensity with the associated day of occurence documented above.

Datatype

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C2700396
UMLS CUI [1,4]
C0042210
Local symptom ongoing after day 6?
Beschrijving

Local symptom ongoing after day 6?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0549178
Date of last day of local symptom (if ongoing after day 6)
Beschrijving

If local symptom was ongoing after day 6, please report the last day of symptom.

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C2700396
UMLS CUI [1,4]
C0042210
Medically attended visit occurred?
Beschrijving

Medically attended visit occured?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C2700396
UMLS CUI [1,5]
C0042210
Specify medically attended visit
Beschrijving

If medically attended visit occured, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C2348235
Solicited adverse events - general symptoms
Beschrijving

Solicited adverse events - general symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
UMLS CUI-4
C4055646
Has the subject experienced any of the following general signs/symptoms at the administration site during the solicited period?
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0042210
Details of general symptoms
Beschrijving

Details of general symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042210
UMLS CUI-3
C1521902
Experienced general symptoms
Beschrijving

Please tick experienced symptom(s) one after the other and specify symptoms below. Fever means Axillary≥ 37.5°C, Oral≥ 37.5°C, Rectal≥ 38°C. Complete measurement location and body temeperature in occurence of fever. For all other symptoms complete intensity instead.

Datatype

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0042210
Local symptom: Day(s) of occurence
Beschrijving

Please fill in the day(s) of occurence one after the other with the associated intensity. In occurence of fever, complete measurement location of body temperature and body temperature as well.

Datatype

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0439228
UMLS CUI [1,5]
C2700396
UMLS CUI [1,6]
C0042210
Location of body temperature measurement
Beschrijving

Complete in occurrence of fever. Rectal measurment is not recommended.

Datatype

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0450429
Body temperature
Beschrijving

Complete in occurrence of fever.

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042210
°C
General symptom: intensity of Fatigue / Headache / Gastronintestinal symptoms / Arthralgia / Rash / Myalgia
Beschrijving

This item has to be filled in occurrence of Fatigue, Headache, Gastronintestinal symptoms, Athralgia, Rash and Myalgia. Gastrointestinal symptoms include nausea, vomiting, diarrhea and / or abdominal pain. Arthralgia (joint pain): only in joints that are distal from the injection site.

Datatype

text

Alias
UMLS CUI [1]
C0518690
UMLS CUI [2]
C0015672
UMLS CUI [3]
C0018681
UMLS CUI [4]
C0426576
UMLS CUI [5]
C0003862
UMLS CUI [6]
C0015230
UMLS CUI [7]
C0231528
General symptom: intensity of Urticaria
Beschrijving

This item has to be filled in in occurrence of Urticaria.

Datatype

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0042109
General symptom ongoing after day 6?
Beschrijving

General symptom ongoing after day 6?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0549178
Date of last day of general symptom (if ongoing after day 6)
Beschrijving

If general symptom was ongoing after day 6, please report the last day of symptom.

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0042210
Medically attended visit occured?
Beschrijving

Medically attended visit occured?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0159028
UMLS CUI [1,4]
C0042210
Specify medically attended visit
Beschrijving

If medically attended visit occurred, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0019993
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C1386497
UMLS CUI [2,3]
C0583237
UMLS CUI [3,1]
C0545082
UMLS CUI [3,2]
C1386497
UMLS CUI [3,3]
C0018724
Is there a reasonable possibility that the adverse event may have been caused by the investigational product?
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0877248
Unsolicited Adverse Events
Beschrijving

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events post vaccination (as per protocol)?
Beschrijving

If YES, fill in the Non-Serious Adverse Event section or Serious Adverse Event report, as appropriate

Datatype

text

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

Solicited adverse events

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Protocol number
Item
Protocol number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Visit number
text
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 1 (Month 0) (Visit 1)
CL Item
Visit 2 (Month 1) (Visit 2)
CL Item
Visit 3 (Month 6) (Visit 3)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Solicited adverse events - local symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C1517001 (UMLS CUI-5)
Item
Has the subject experienced any of the following local signs/symptoms at the administration site during the solicited period?
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
Experience of solicited adverse events
Code List
Has the subject experienced any of the following local 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
Details of local symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0042210 (UMLS CUI-4)
C1521902 (UMLS CUI-5)
C1517001 (UMLS CUI-6)
Item
Experienced local symptoms
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
Experienced local symptoms
Code List
Experienced local symptoms
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Item
Local symptom: Day(s) of occurence
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
Redness: Day(s) of occurence
Code List
Local symptom: Day(s) of occurence
CL Item
Day 0 (Day 0)
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 3 (Day 3)
CL Item
Day 4 (Day 4)
CL Item
Day 5 (Day 5)
CL Item
Day 6 (Day 6)
Local symptom: size (mm)
Item
Local symptom: size (mm)
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C2700396 (UMLS CUI [2,3])
C0042210 (UMLS CUI [2,4])
Item
Local symptom: intensity
integer
C0030193 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
Local symptom: intensity
Code List
Local symptom: intensity
CL Item
Absent (0)
CL Item
Painful on touch (1)
CL Item
Painful when limb is moved (2)
CL Item
painful that prevents normal activity (3)
Local symptom ongoing after day 6?
Item
Local symptom ongoing after day 6?
boolean
C1457887 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Date of last day of local symptom
Item
Date of last day of local symptom (if ongoing after day 6)
date
C0011008 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
Medically attended visit occured?
Item
Medically attended visit occurred?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])
C0042210 (UMLS CUI [1,5])
Item
Specify medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Specify medically attended visit
Code List
Specify 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)
C4055646 (UMLS CUI-4)
Item
Has the subject experienced any of the following general signs/symptoms at the administration site during the solicited period?
text
C0159028 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Experience of solicited adverse events
Code List
Has the subject experienced any of the following general 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
Details of general symptoms
C0159028 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
C1521902 (UMLS CUI-3)
Item
Experienced general symptoms
text
C0159028 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Experienced general symptoms
Code List
Experienced general symptoms
CL Item
Fever (1)
CL Item
Fatigue (2)
CL Item
Headache (3)
CL Item
Gastrointestinal symptoms (4)
CL Item
Athralgia (5)
CL Item
Myalgia (6)
CL Item
Rash (7)
CL Item
Urticaria (8)
Item
Local symptom: Day(s) of occurence
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,4])
C2700396 (UMLS CUI [1,5])
C0042210 (UMLS CUI [1,6])
Redness: Day(s) of occurence
Code List
Local symptom: Day(s) of occurence
CL Item
Day 0 (Day 0)
CL Item
Day 1 (Day 1)
CL Item
Day 2 (Day 2)
CL Item
Day 3 (Day 3)
CL Item
Day 4 (Day 4)
CL Item
Day 5 (Day 5)
CL Item
Day 6 (Day 6)
Item
Location of body temperature measurement
text
C0005903 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Location of body temperature measurement
Code List
Location of body temperature measurement
CL Item
Axillary ([A])
CL Item
Oral ([O])
CL Item
Rectal ([R])
CL Item
Not taken ([NT])
Body temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
General symptom: intensity of Fatigue / Headache / Gastronintestinal symptoms / Arthralgia / Rash / Myalgia
text
C0518690 (UMLS CUI [1])
C0015672 (UMLS CUI [2])
C0018681 (UMLS CUI [3])
C0426576 (UMLS CUI [4])
C0003862 (UMLS CUI [5])
C0015230 (UMLS CUI [6])
C0231528 (UMLS CUI [7])
Local symptom: intensity
Code List
General symptom: intensity of Fatigue / Headache / Gastronintestinal symptoms / Arthralgia / Rash / Myalgia
CL Item
Normal (0)
CL Item
Symptoms that are easily tolerated (1)
CL Item
Symptoms that interfere with normal activity (2)
CL Item
Symptoms that prevent normal activity (3)
Item
General symptom: intensity of Urticaria
text
C0518690 (UMLS CUI [1,1])
C0042109 (UMLS CUI [1,2])
General symptom: intensity of Urticaria
Code List
General symptom: intensity of Urticaria
CL Item
Normal (0)
CL Item
Urticaria distributed on a single body area only (1)
CL Item
Urticaria distributed on 2 or 3 body areas but not more (2)
CL Item
Urticaria distributed on at least 4 body areas (3)
General symptom ongoing after day 6?
Item
General symptom ongoing after day 6?
boolean
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of general symptom
Item
Date of last day of general symptom (if ongoing after day 6)
date
C0011008 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Medically attended visit occured?
Item
Medically attended visit occured?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
Item
Specify medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C0545082 (UMLS CUI [2,1])
C1386497 (UMLS CUI [2,2])
C0583237 (UMLS CUI [2,3])
C0545082 (UMLS CUI [3,1])
C1386497 (UMLS CUI [3,2])
C0018724 (UMLS CUI [3,3])
Specify medically attended visit
Code List
Specify medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Causality to investigational product
Item
Is there a reasonable possibility that the adverse event may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
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 post vaccination (as per protocol)?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Experience of unsolicited adverse events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events post vaccination (as per protocol)?
CL Item
Information not available ([U])
CL Item
No vaccine administered ([NA])
CL Item
No ([N])
CL Item
Yes ([Y])
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