ID

29748

Beschreibung

https://clinicaltrials.gov/show/NCT00197028 Sample Case Report Form Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

Link

https://clinicaltrials.gov/show/NCT00197028

Stichworte

Versionen (1)
  1. 18.04.18 18.04.18 -
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GlaxoSmithKline (GSK)

Hochgeladen am

18. April 2018

DOI

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RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028

Englisch

Sample Case Report Form: Laboratory Reference Ranges and Serious Adverse Events

1 Formulare  
Laboratory Reference Ranges
Beschreibung

Laboratory Reference Ranges

Alias
UMLS CUI-1
C0883335
Laboratory Name
Beschreibung

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C1882331
Lab Code
Beschreibung

Laboratory Code

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0600091
Reference Range
Beschreibung

Reference Range

Alias
UMLS CUI-1
C0883335
Date these reference ranges became effective:
Beschreibung

Date of reference range

Datentyp

date

Alias
UMLS CUI [1,1]
C0883335
UMLS CUI [1,2]
C0011008
Age range: low - high
Beschreibung

Age range

Datentyp

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1514721
Age units (tick one box)
Beschreibung

Age units

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0001779
Sex
Beschreibung

Sex

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Lab test: Biochemistry and Haematology
Beschreibung

Laboratory Test

Datentyp

integer

Alias
UMLS CUI [1]
C0022885
Unit
Beschreibung

Laboratory test unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Low Reference Value
Beschreibung

Low Reference Value

Datentyp

float

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C1522609
UMLS CUI [1,3]
C0205251
High Reference value
Beschreibung

High Reference value

Datentyp

float

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C1522609
UMLS CUI [1,3]
C0205250
Serious adverse events
Beschreibung

Serious adverse events

Alias
UMLS CUI-1
C1519255
Center number
Beschreibung

Center number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Country
Beschreibung

Country

Datentyp

text

Alias
UMLS CUI [1]
C0454664
GSK Receipt Date
Beschreibung

GSK Receipt Date

Datentyp

date

Alias
UMLS CUI [1]
C2985846
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Type of information
Beschreibung

Type of information

Datentyp

integer

Alias
UMLS CUI [1]
C1508263
SAE N°
Beschreibung

Serious adverse event number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Section 1
Beschreibung

Section 1

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1828479
Diagnosis only (if known), otherwise sign / symptom
Beschreibung

Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1]
C2697888
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]
C2697886
Maximum intensity
Beschreibung

Maximum intensity

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
Action taken with investigational product(s) as a result of the SAE
Beschreibung

Action taken with investigational product(s)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE? (*)
Beschreibung

(*) If yes, please complete the Study Conclusion page in the CRF of the subject and tick SAE as reason for withdrawal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschreibung

Relationship to investigational product(s)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Medically attended visit?
Beschreibung

HO:Hospitalisation ER:Emergency Room MD:Medical Doctor Refer to protocol for full definition

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1519255
Was a post-mortem / autopsy performed?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Section 2
Beschreibung

Section 2

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C1710056
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
Section 3 - Demography Data
Beschreibung

Section 3 - Demography Data

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0011298
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 (US only)
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • pounds/ounces
Alias
UMLS CUI [1]
C0005910
pounds/ounces
Section 4
Beschreibung

Section 4

Alias
UMLS CUI-1
C1828479
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
Beschreibung

Recurrence of reported event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0034897
Section 5 - Causes of SAE
Beschreibung

Section 5 - Causes of SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
Possible causes of SAE other than investigational product: (tick all that apply)
Beschreibung

Causes of SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Section 6 – Relevant Medical Conditions
Beschreibung

Section 6 – Relevant Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0262926
UMLS CUI-3
C1519255
Specify any relevant past or current medical disorders, allergies, surgeries, etc., that can help explain the SAE
Beschreibung

Medical disorders

Datentyp

text

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0543467
Date of onset
Beschreibung

Date of onset

Datentyp

date

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

Present condition

Datentyp

boolean

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

Date of last occurence

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C2745955
Section 7 - Other relevant risk factors
Beschreibung

Section 7 - Other relevant risk factors

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0035648
Other relevant risk factors: (specify any family or social history (smoking, diet, drug abuse, occupational hazard) relevant to the SAE):
Beschreibung

Other relevant risk factors

Datentyp

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
Section 8 – Relevant Concomitant Medications
Beschreibung

Section 8 – Relevant Concomitant Medications

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C2347852
Drug Name (Trade name preferred)
Beschreibung

Drug name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Dose
Beschreibung

Dose

Datentyp

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beschreibung

Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Taken prior to study?
Beschreibung

Concomitant Medications

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Date started
Beschreibung

Date started

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Date stopped
Beschreibung

Date stopped

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Ongoing?
Beschreibung

Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for medication
Beschreibung

Reason for medication

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Section 9 – Details of investigational product(s)
Beschreibung

Section 9 – Details of investigational product(s)

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0013230
UMLS CUI-3
C1522508
Vaccine (specify mixed or separate)
Beschreibung

Vaccine

Datentyp

text

Alias
UMLS CUI [1]
C0042210
Dose N°
Beschreibung

Dose number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115464
UMLS CUI [1,2]
C0042210
Lot N°
Beschreibung

Lot number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826710
UMLS CUI [1,2]
C0042210
Route / site
Beschreibung

Route / site

Datentyp

text

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

Administration date

Datentyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Was randomization code broken at investigational site?
Beschreibung

Randomization code

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0443289
Section 10 – Details of relevant assessments
Beschreibung

Section 10 – Details of relevant assessments

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0220825
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)
Beschreibung

Details of relevant assessments

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C1522508
Section 11 – Narrative remarks
Beschreibung

Section 11 – Narrative remarks

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0947611
Narrative remarks: (provide a brief narrative description of the SAE and details of treatment given):
Beschreibung

Narrative remarks

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Section 12 – SAE additional / follow-up information
Beschreibung

Section 12 – SAE additional / follow-up information

Alias
UMLS CUI-1
C1524062
UMLS CUI-2
C1533716
UMLS CUI-3
C1519255
UMLS CUI-4
C1522577
SAE additional / follow-up information (use this page to provide any additional details on the SAE not already captured on the previous pages):
Beschreibung

SAE additional / follow-up information

Datentyp

text

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1522577
Administative data
Beschreibung

Administative data

Alias
UMLS CUI-1
C1320722
Investigator’s signature:
Beschreibung

Investigator’s signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Please PRINT name:
Beschreibung

Printed name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Sample Case Report Form: Laboratory Reference Ranges and Serious Adverse Events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Laboratory Reference Ranges
C0883335 (UMLS CUI-1)
Laboratory Name
Item
Laboratory Name
text
C1882331 (UMLS CUI [1])
Laboratory Code
Item
Lab Code
integer
C0022877 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Reference Range
C0883335 (UMLS CUI-1)
Date of reference range
Item
Date these reference ranges became effective:
date
C0883335 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Age range
Item
Age range: low - high
integer
C0001779 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
Item
Age units (tick one box)
integer
C1519795 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Age units
Code List
Age units (tick one box)
CL Item
years (1)
CL Item
months (2)
CL Item
weeks (3)
CL Item
days (4)
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male reference range (1)
CL Item
Female reference range (2)
CL Item
Male and Female reference range (3)
Item
Lab test: Biochemistry and Haematology
integer
C0022885 (UMLS CUI [1])
Laboratory Test
Code List
Lab test: Biochemistry and Haematology
CL Item
ALT (1)
CL Item
Creatinine (2)
CL Item
Bilirubin (3)
CL Item
Haemoglobin (4)
CL Item
WBC (White blood cells) total: (5)
CL Item
PCV (Packed cell volume)/ Haematocrit (6)
CL Item
Platelets (7)
Laboratory test unit
Item
Unit
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Low Reference Value
Item
Low Reference Value
float
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
High Reference value
Item
High Reference value
float
C0587081 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Item Group
Serious adverse events
C1519255 (UMLS CUI-1)
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
GSK Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Type of information
integer
C1508263 (UMLS CUI [1])
Type of information
Code List
Type of information
CL Item
Initial report (1)
CL Item
Additional information (2)
CL Item
Additional information (3)
CL Item
Additional information (4)
Serious adverse event number
Item
SAE N°
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Section 1
C1519255 (UMLS CUI-1)
C1828479 (UMLS CUI-2)
Event
Item
Diagnosis only (if known), otherwise sign / symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Start date
Item
Start date
date
C2697888 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
1: Recovered/ Resolved (1)
CL Item
2: Recovering / Resolving (2)
CL Item
3: Not recovered/ Not resolved (3)
CL Item
4: Recovered/ Resolved with sequelae (4)
CL Item
5: Fatal (5)
End date
Item
End date
date
C2697886 (UMLS CUI [1])
Item
Maximum intensity
integer
C1710066 (UMLS CUI [1])
Maximum intensity
Code List
Maximum intensity
CL Item
1: Mild (1)
CL Item
2: Moderate (2)
CL Item
3: Severe (3)
CL Item
X:Not applicable (4)
Item
Action taken with investigational product(s) as a result of the SAE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action taken with investigational product(s)
Code List
Action taken with investigational product(s) as a result of the SAE
CL Item
1: Investigational product(s) withdrawn (1)
CL Item
2: Dose not changed (2)
CL Item
3: Dose Interrupted (3)
CL Item
X:Not applicable (4)
Withdrawal
Item
Did the subject withdraw from study as a result of this SAE? (*)
boolean
C2349954 (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?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Medically attended visit?
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit?
CL Item
[HO] (1)
CL Item
[ER] (2)
CL Item
[MD] (3)
Autopsy
Item
Was a post-mortem / autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Section 2
C1828479 (UMLS CUI-1)
C1710056 (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
Results in disability / incapacity (2)
CL Item
Is life threatening (3)
CL Item
Congenital anomaly / birth defect in the offspring (4)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (5)
CL Item
Other, specify: ___________________________________________________ (6)
CL Item
___________________________________________________ (7)
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
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 (US only)
integer
C0005910 (UMLS CUI [1])
Item Group
Section 4
C1828479 (UMLS CUI-1)
Item
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
integer
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Recurrence of reported event
Code List
If investigational product was stopped, did the reported event(s) recur after further investigational 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 Group
Section 5 - Causes of SAE
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
Item
Possible causes of SAE other than investigational product: (tick all that apply)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Causes of SAE
Code List
Possible causes of SAE other than investigational product: (tick all that apply)
CL Item
Disease under study (1)
CL Item
Concomitant medication (record in Section 8) (2)
CL Item
Medical condition(s) (record in Section 6) (3)
CL Item
Activity related to study participation (e.g. procedures) (4)
CL Item
Lack of efficacy (5)
CL Item
Withdrawal of investigational product (6)
CL Item
Other, specify: ____________________________________________________ (7)
CL Item
____________________________________________________ (8)
Item Group
Section 6 – Relevant Medical Conditions
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Medical disorders
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc., that can help explain the SAE
text
C0012634 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Present condition
Item
Condition present at time of SAE?
boolean
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Date of last occurence
Item
If no, date of last occurrence
date
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
Item Group
Section 7 - Other relevant risk factors
C1828479 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Other relevant risk factors
Item
Other relevant risk factors: (specify any family or social history (smoking, diet, drug abuse, occupational hazard) relevant to the SAE):
text
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 (Trade name preferred)
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant Medications
Item
Taken prior to study?
boolean
C2347852 (UMLS CUI [1])
Date started
Item
Date started
date
C2826734 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Ongoing
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Item Group
Section 9 – Details of investigational product(s)
C1828479 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Vaccine
Item
Vaccine (specify mixed or separate)
text
C0042210 (UMLS CUI [1])
Dose number
Item
Dose N°
integer
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Lot number
Item
Lot N°
integer
C2826710 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route / site
Item
Route / site
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])
Administration date
Item
Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Was randomization code broken at investigational site?
integer
C0034656 (UMLS CUI [1,1])
C0443289 (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)
Item Group
Section 10 – Details of relevant assessments
C1828479 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
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
C1519255 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item Group
Section 11 – Narrative remarks
C1828479 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
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
Section 12 – SAE additional / follow-up information
C1524062 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
SAE additional / follow-up information
Item
SAE additional / follow-up information (use this page to provide any additional details on the SAE not already captured on the previous pages):
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
Item Group
Administative data
C1320722 (UMLS CUI-1)
Investigator’s signature
Item
Investigator’s signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed name
Item
Please PRINT name:
text
C2826892 (UMLS CUI [1])
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