ID

23021

Beschreibung

Study ID: 100484 Clinical Study ID: 100484 (DTPa) Study Title: An open prospective study of immunogenicity and reactogenicity of DTPa vaccine (Infanrix) given as a booster to healthy school children 10 to 12 years of age Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed Trade Name: BIO DTPA (INFANRIX); Infanrix Study Indication: Acellular Pertussis; Diphtheria; Tetanus; acellular pertussis Documentation: Serious Adverse Event

Stichworte

Versionen (1)
  1. 20.06.17 20.06.17 -
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GlaxoSmithKline

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20. Juni 2017

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Serious Adverse Event: GSK DTPa vaccine (Infanrix) 100484

Englisch

Study ID: 100484 Serious Adverse Event

1 Formulare  
Serious Adverse Events
Beschreibung

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Center
Beschreibung

Center

Datentyp

text

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Country
Beschreibung

Country

Datentyp

text

Alias
UMLS CUI [1]
C0454664
GSK Receipt Date
Beschreibung

Receipt Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1514756
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Type of report
Beschreibung

Type of report

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C1519255
SAE Number
Beschreibung

Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Serious adverse events: Diagnosis only (if known) or signs / symptoms
Beschreibung

Serious adverse event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschreibung

Start Date

Datentyp

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
End Date
Beschreibung

If fatal, record date of death

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C1148348
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Action taken with investigational product(s) as a result of the non-serious AE
Beschreibung

Action taken with investigational product

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did subject withdraw from study as a result of this serious AE?
Beschreibung

Withdrawal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
Beschreibung

Relationship to investigational product(s)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Medical advice
Beschreibung

Medical advice

Datentyp

text

Alias
UMLS CUI [1]
C1386497
UMLS CUI [2]
C1519255
If fatal, was a post-mortem/autopsy performed?
Beschreibung

If yes, summarize findings in narrative remarks section of this SAE form.

Datentyp

text

Alias
UMLS CUI [1]
C0004398
UMLS CUI [2]
C1519255
Seriousness, (specify reason(s) for considering this a SAE, tick all that apply):
Beschreibung

Seriousness

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Seriousness, if other please specify
Beschreibung

Seriousness

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight
Beschreibung

For US in Pounds and Ounces

Datentyp

integer

Maßeinheiten
  • pounds
Alias
UMLS CUI [1]
C0005910
pounds
Weight
Beschreibung

For US in Pounds and Ounces

Datentyp

integer

Maßeinheiten
  • ounces
Alias
UMLS CUI [1]
C0005910
ounces
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
Beschreibung

recur of event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Possible Causes of SAE other than Investigational Product(s), tick all that apply:
Beschreibung

Cause of SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Please specify cause of SAE if Other
Beschreibung

Cause of SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Beschreibung

Relevant Medical Conditions

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1519255
Date of onset
Beschreibung

Specify any RELEVANT past or current medical disorders, allergies, Date of Onset Condition Present at Time of the If No, Date of Last OccutTence surgeries, etc. that can help explain the SAE

Datentyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C1519255
Condition present at time of the SAE?
Beschreibung

Condition present at time of the SAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519255
If NO, date of last occurrence
Beschreibung

date of last occurrence

Datentyp

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
UMLS CUI [2]
C1519255
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
Beschreibung

Other relevant risk factors

Datentyp

text

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Drug, Trade name preferred
Beschreibung

Include any concomitant medications that may contribute to the occurrence of the SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Dose
Beschreibung

Dose

Datentyp

float

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Taken Prior to Study?
Beschreibung

Taken Prior to Study

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Stop date
Beschreibung

Stop date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Ongoing Medication?
Beschreibung

Continued

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3494713
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Reason for Medication
Beschreibung

indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Vaccine (specify mixed or separate)
Beschreibung

Vaccine

Datentyp

text

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Dose Number
Beschreibung

Dose Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115464
UMLS CUI [1,2]
C0042210
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Lot Number
Beschreibung

Lot Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C0042210
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [2]
C1519255
Details of Investigational Product(s): Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042210
UMLS CUI [2]
C1519255
Was randomization code broken at investigational site?
Beschreibung

randomization code

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0805701
Details of Relevant Assessments
Beschreibung

Provide details of other assessments (e.g., laboratory data with normal ranges) or supplemental examinations.

Datentyp

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
Narrative remarks
Beschreibung

(provide a brief narrative description of the SAE and details of treatment given):

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
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Ähnliche Modelle

Study ID: 100484 Serious Adverse Event

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Center
Item
Center
text
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Receipt Date
Item
GSK Receipt Date
date
C0011008 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Type of report
integer
C2348792 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Type of report
Code List
Type of report
CL Item
Initial report (1)
CL Item
Additional info (2)
Number
Item
SAE Number
text
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Serious adverse event
Item
Serious adverse events: Diagnosis only (if known) or signs / symptoms
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date
text
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered /resolved (1)
CL Item
Recovering /resolving (2)
CL Item
Not recovered /not resolved (3)
CL Item
Recovered /resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action taken with investigational product
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Dose Interrupted (3)
CL Item
Not applicable (4)
Withdrawal
Item
Did subject withdraw from study as a result of this serious AE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to investigational product(s)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product(s)?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Medical advice
text
C1386497 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Medical advice
Code List
Medical advice
CL Item
Hospitalisation (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
autopsy
Item
If fatal, was a post-mortem/autopsy performed?
text
C0004398 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item
Seriousness, (specify reason(s) for considering this a SAE, tick all that apply):
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness
Code List
Seriousness, (specify reason(s) for considering this a SAE, tick all that apply):
CL Item
Results in death  (1)
CL Item
Is life threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability / incapacity (4)
CL Item
Congenital anomaly / birth defect in the offspring (5)
CL Item
Other (6)
Seriousness
Item
Seriousness, if other please specify
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
recur of event
Code List
If lnvestigational Product was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) Were Administered?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
Possible Causes of SAE other than Investigational Product(s), tick all that apply:
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Cause of SAE
Code List
Possible Causes of SAE other than Investigational Product(s), tick all that apply:
CL Item
Disease under study  (1)
CL Item
Medical condition(s) (record in Section 6)  (2)
CL Item
Lack of efficacy  (3)
CL Item
Withdrawal of investigational product (4)
CL Item
Concomitant medication (record in Section 8) (5)
CL Item
Activity related to study participation (e.g. procedures) (6)
CL Item
Other (7)
Cause of SAE
Item
Please specify cause of SAE if Other
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relevant Medical Conditions
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Condition present at time of the SAE
Item
Condition present at time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
date of last occurrence
Item
If NO, date of last occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
Other relevant risk factors
Item
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C0035648 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Drug
Item
Relevant Concomitant Medications: Drug, Trade name preferred
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Dose
Item
Relevant Concomitant Medications: Dose
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Unit
Item
Relevant Concomitant Medications: Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Frequency
Item
Relevant Concomitant Medications: Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Route
Item
Relevant Concomitant Medications: Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Start Date
Item
Relevant Concomitant Medications: Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Taken Prior to Study
Item
Relevant Concomitant Medications: Taken Prior to Study?
boolean
C2347852 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Stop date
Item
Relevant Concomitant Medications: Stop date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Continued
Item
Relevant Concomitant Medications: Ongoing Medication?
boolean
C2347852 (UMLS CUI [1,1])
C3494713 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
indication
Item
Relevant Concomitant Medications: Reason for Medication
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Vaccine
Item
Details of Investigational Product(s): Vaccine (specify mixed or separate)
text
C0042210 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Dose Number
Item
Details of Investigational Product(s): Dose Number
integer
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Lot Number
Item
Details of Investigational Product(s): Lot Number
integer
C1115660 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Route
Item
Details of Investigational Product(s): Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Site
Item
Details of Investigational Product(s): Site
text
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Date
Item
Details of Investigational Product(s): Date
date
C0011008 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item
Was randomization code broken at investigational site?
integer
C0034656 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
randomization code
Code List
Was randomization code broken at investigational site?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (3)
Details of Relevant Assessments
Item
Details of Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Narrative remarks
Item
Narrative remarks
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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