ID

29704

Beschrijving

A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Study ID:103792 Clinical Study ID:103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus CRF Seiten: 375-430

Trefwoorden

Versies (1)
  1. 13-04-18 13-04-18 -
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GlaxoSmithKline

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13 april 2018

DOI

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Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study NCT00289172

Engels

Serious Adverse Event

1 Formulieren  
  1. StudyEvent: ODM
    1. Serious Adverse Event
Header
Beschrijving

Header

Alias
UMLS CUI-1
C1320722
Center
Beschrijving

Center

Datatype

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
SECTION 1: Serious adverse event
Beschrijving

SECTION 1: Serious adverse event

Alias
UMLS CUI-1
C1519255
Event
Beschrijving

Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE however if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page.

Datatype

text

Alias
UMLS CUI [1]
C0877248
Start Date
Beschrijving

Record the start date of the first occurrence of the SAE.

Datatype

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beschrijving

All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.

Datatype

integer

Alias
UMLS CUI [1]
C1705586
End Date
Beschrijving

Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

Datatype

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Beschrijving

Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild= An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate=An event that is sufficiently discomforting to interfere with normal everyday activities. Severe= An event that prevents normal everyday activities. Not applicable=those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).

Datatype

text

Alias
UMLS CUI [1]
C0518690
Action Taken with IP in REDUCE Study or Prescription Dutasteride as a Result of the SAE
Beschrijving

IP in REDUCE study or prescription dutasteride withdrawn = Administration of IP in REDUCE study or prescription dutasteride was permanently discontinued. Dose reduced = Dose is reduced for IP in REDUCE study or prescription dutasteride. Dose increased = Dose increased for IP in REDUCE study or prescription dutasteride. Dose not changed = IP in REDUCE study or prescription dutasteride continues even though an adverse event has occurred. Dose interrupted = Administration of IP in REDUCE study or prescription dutasteride was temporarily interrupted but then restarted. Not applicable =Subject was not receiving IP in REDUCE study or prescription dutasteride when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).

Datatype

text

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C2830183
Did the subject withdraw from study as a result of this SAE?
Beschrijving

Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’.

Datatype

text

Alias
UMLS CUI [1]
C0422727
Is there a reasonable possibility the SAE may have been caused by IP in REDUCE study or prescription dutasteride?
Beschrijving

It is a regulatory requirement for investigators to assess relationship to investigational product in REDUCE study or prescription dutasteride based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
If Yes, specify reason
Beschrijving

reason

Datatype

integer

Alias
UMLS CUI [1]
C0566251
Section 2: Seriousness
Beschrijving

Section 2: Seriousness

[A] Results in death
Beschrijving

SAE results in death

Datatype

boolean

Alias
UMLS CUI [1]
C0011065
[B] Is life-threatening
Beschrijving

SAE is life-threatening

Datatype

boolean

Alias
UMLS CUI [1]
C2826244
[C] Requires hospitalisation or prolongation of existing hospitalisation
Beschrijving

SAE requires hospitalisation

Datatype

boolean

Alias
UMLS CUI [1]
C0019993
[D] Results in disability/incapacity
Beschrijving

SAE results in disability/incapacity

Datatype

boolean

Alias
UMLS CUI [1]
C0231170
[E] Congenital anomaly/birth defect
Beschrijving

Congenital anomaly/birth defect

Datatype

boolean

Alias
UMLS CUI [1]
C0000768
[F] Other
Beschrijving

Óther SAE

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
Other, specify
Beschrijving

Other SAE specificationn

Datatype

text

Alias
UMLS CUI [1]
C3845569
SECTION 3 Demography Data
Beschrijving

SECTION 3 Demography Data

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0011298
Date of birth
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
SECTION 4
Beschrijving

SECTION 4

Investigational Product
Beschrijving

If lnvestigational Product(s) was Stopped

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
SECTION 5
Beschrijving

SECTION 5

Possible Causes of SAE
Beschrijving

Possible Causes of SAE

Datatype

integer

Alias
UMLS CUI [1,1]
C3828190
UMLS CUI [1,2]
C1519255
SECTION 6: RELEVANT Medical Conditions
Beschrijving

SECTION 6: RELEVANT Medical Conditions

Alias
UMLS CUI-1
C0262926
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Beschrijving

Relevant Medical Conditions

Datatype

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Date of onset
Beschrijving

Date of onset

Datatype

date

Alias
UMLS CUI [1]
C0574845
Condition Present at Time of the SAE?
Beschrijving

continuation SAE

Datatype

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence
Beschrijving

Date of Last Occurrence

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2745955
Section 7
Beschrijving

Section 7

Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Beschrijving

Other risk factors relevant to SAE

Datatype

integer

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
SECTION 8 RELEVANT Concomitant Medications
Beschrijving

SECTION 8 RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C2347852
Drug Name
Beschrijving

Drug Name

Datatype

text

Alias
UMLS CUI [1]
C0013227
Dose
Beschrijving

Dose

Datatype

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beschrijving

Unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Beschrijving

Taken Prior to Study?

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschrijving

Stop Date

Datatype

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beschrijving

Ongoing Medication?

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschrijving

Reason for Medication

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Section 9 - Details of investigational product
Beschrijving

Section 9 - Details of investigational product

Alias
UMLS CUI-1
C0304229
Vaccine (specify mixed or seperate)
Beschrijving

Vaccine

Datatype

text

Alias
UMLS CUI [1]
C0042210
Dose N°
Beschrijving

Dose

Datatype

text

Alias
UMLS CUI [1]
C0178602
Lot N°
Beschrijving

Lot

Datatype

text

Alias
UMLS CUI [1]
C1115660
Route / Site
Beschrijving

Route / Site

Datatype

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [2,1]
C0013153
UMLS CUI [2,2]
C0042210
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Section 10
Beschrijving

Section 10

Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
Beschrijving

Details of relevant assessments

Datatype

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
Section 11
Beschrijving

Section 11

Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Beschrijving

Narrative Remarks

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigator's signature
Beschrijving

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschrijving

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Beschrijving

Printed Investigator's name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Date
Beschrijving

Date of investigator's signature

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
SECTION 12 – SAE additional / follow-up information
Beschrijving

SECTION 12 – SAE additional / follow-up information

Alias
UMLS CUI-1
C0807975
UMLS CUI-2
C1519255
Use this page to provide any additional details on the SAE not already captured on the previous pages:
Beschrijving

follow-up information SAE

Datatype

text

Alias
UMLS CUI [1,1]
C0807975
UMLS CUI [1,2]
C1519255
Investigator’s signature:
Beschrijving

Investigator signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Serious Adverse Event

1 Formulieren
  1. StudyEvent: ODM
    1. Serious Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
SECTION 1: Serious adverse event
C1519255 (UMLS CUI-1)
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
C1709863 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
(Comment:en)
CL Item
Recovered/Resolved with sequelae (4)
(Comment:en)
CL Item
Fatal (5)
C1302234 (UMLS CUI-1)
(Comment:en)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
Action Taken with IP in REDUCE Study or Prescription Dutasteride as a Result of the SAE
text
C2826626 (UMLS CUI [1,1])
C2830183 (UMLS CUI [1,2])
Action Taken with IP
Code List
Action Taken with IP in REDUCE Study or Prescription Dutasteride as a Result of the SAE
CL Item
IP in REDUCE study or prescription dutasteride withdrawn (1)
(Comment:en)
CL Item
Dose reduced (2)
C1707814 (UMLS CUI-1)
(Comment:en)
CL Item
Dose increased (3)
C1707810 (UMLS CUI-1)
(Comment:en)
CL Item
Dose not changed (4)
C0178602 (UMLS CUI-1)
C0443172 (UMLS CUI-2)
(Comment:en)
CL Item
Dose interrupted (5)
C1512900 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
Did the subject withdraw from study as a result of this SAE?
text
C0422727 (UMLS CUI [1])
Withdrawal
Code List
Did the subject withdraw from study as a result of this SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility the SAE may have been caused by IP in REDUCE study or prescription dutasteride?
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Cause of Adverse event
Code List
Is there a reasonable possibility the SAE may have been caused by IP in REDUCE study or prescription dutasteride?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, specify reason
integer
C0566251 (UMLS CUI [1])
Relationship to IP in REDUCE specification
Code List
If Yes, specify reason
CL Item
Prior use of IP in REDUCE study (1)
CL Item
Prescription dutasteride (2)
CL Item
Unable to distinguish (3)
Item Group
Section 2: Seriousness
SAE results in death
Item
[A] Results in death
boolean
C0011065 (UMLS CUI [1])
SAE is life-threatening
Item
[B] Is life-threatening
boolean
C2826244 (UMLS CUI [1])
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
Congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1])
Óther SAE
Item
[F] Other
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Other SAE specificationn
Item
Other, specify
text
C3845569 (UMLS CUI [1])
Item Group
SECTION 3 Demography Data
C1828479 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
SECTION 4
Item
Investigational Product
integer
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
If lnvestigational Product(s) was Stopped
Code List
Investigational Product
CL Item
Yes (1)
(Comment:en)
CL Item
No (2)
(Comment:en)
CL Item
Unknown at this time (3)
(Comment:en)
CL Item
Not applicable (4)
(Comment:en)
Item Group
SECTION 5
Item
Possible Causes of SAE
integer
C3828190 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Possible Causes of SAE
Code List
Possible Causes of SAE
CL Item
Disease under study (1)
C0012634 (UMLS CUI-1)
(Comment:en)
CL Item
Concomitant medication (2)
C2347852 (UMLS CUI-1)
(Comment:en)
CL Item
Medical condition (3)
C1699700 (UMLS CUI-1)
(Comment:en)
CL Item
Activity related to study participation (e.g., procedures) (4)
C2348568 (UMLS CUI-1)
(Comment:en)
CL Item
Lack of efficacy (5)
C0235828 (UMLS CUI-1)
(Comment:en)
CL Item
Other, specify ______________________ (6)
C2911685 (UMLS CUI-1)
C1521902 (UMLS CUI-2)
(Comment:en)
CL Item
Withdrawal of investigational product(s) (7)
C2349954 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
(Comment:en)
Item Group
SECTION 6: RELEVANT Medical Conditions
C0262926 (UMLS CUI-1)
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 [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Condition Present at Time of the SAE?
text
C0805733 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Condition Present at Time of the SAE
Code List
Condition Present at Time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C0011008 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Item Group
Section 7
Other risk factors relevant to SAE
Item
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
integer
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 8 RELEVANT Concomitant Medications
C1828479 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Section 9 - Details of investigational product
C0304229 (UMLS CUI-1)
Vaccine
Item
Vaccine (specify mixed or seperate)
text
C0042210 (UMLS CUI [1])
Dose
Item
Dose N°
text
C0178602 (UMLS CUI [1])
Lot
Item
Lot N°
text
C1115660 (UMLS CUI [1])
Route / Site
Item
Route / Site
text
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0013153 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Section 10
Details of relevant assessments
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Section 11
Narrative Remarks
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of investigator's signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
SECTION 12 – SAE additional / follow-up information
C0807975 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
follow-up information SAE
Item
Use this page to provide any additional details on the SAE not already captured on the previous pages:
text
C0807975 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigator signature
Item
Investigator’s signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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