ID

37506

Beschrijving

Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Trefwoorden

Laboratories

Substance-Related Disorders

Electrocardiogram (ECG)

26-07-19 26-07-19 -
04-08-19 04-08-19 -

Houder van rechten

GlaxoSmithKline

Geüploaded op

4 augustus 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

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Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957

model
Details

Follow-up - Vital Signs; 12-Lead ECG; Electronically Transferred Lab Data; Urinalysis; Study Conclusion; Pregnancy Information

1 Formulieren

StudyEvent: ODM
1. Follow-up - Vital Signs; 12-Lead ECG; Electronically Transferred Lab Data; Urinalysis; Study Conclusion; Pregnancy Information

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Date of Visit

Item Group

Date of Visit

C1320303 (UMLS CUI-1)

Date of Visit

Item

Date of Visit

date

C1320303 (UMLS CUI [1])

Vital Signs - Semi-Supine

Item Group

Vital Signs - Semi-Supine

C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0522019 (UMLS CUI-3)

Vital Signs - Semi-Supine - Actual date/time

Item

Vital Signs - Semi-Supine - Actual date/time

datetime

C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])

Systolic Blood pressure - Semi-Supine

Item

Systolic Blood pressure - Semi-Supine

integer

C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])

Diastolic Blood pressure - Semi-Supine

Item

Diastolic Blood pressure - Semi-Supine

integer

C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])

Temperature - Semi-supine

Item

Temperature - Semi-supine

text

C0005903 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])

Vital signs Predose - Semi-supine - Heart rate

Item

Vital signs - Semi-supine - Heart rate

integer

C0018810 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,3])

Respiration rate - Semi-Supine

Item

Respiration rate - Semi-Supine

integer

C0231832 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,3])

Vital Signs - Standing

Item Group

Vital Signs - Standing

C0518766 (UMLS CUI-1)
C0231472 (UMLS CUI-2)

Vital Signs - Standing - Actual date/time

Item

Vital Signs - Standing - Actual date/time

datetime

C0518766 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])

Systolic Blood pressure - Standing

Item

Systolic Blood pressure - Standing

integer

C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])

Diastolic Blood pressure Pre-dose - Standing

Item

Diastolic Blood pressure Pre-dose - Standing

integer

C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])

Vital signs - Standing - Heart rate

Item

Vital signs - Standing - Heart rate

integer

C0018810 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,3])

12-Lead ECG

Item Group

12-Lead ECG

C0430456 (UMLS CUI-1)

Date and Time of ECG

Item

Date and Time of ECG

datetime

C2826846 (UMLS CUI [1])

12-Lead ECG - Hart rate

Item

12-Lead ECG - Hart rate

integer

C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])

PR Intreval

Item

PR Intreval

integer

C0429087 (UMLS CUI [1])

QRS Duration

Item

QRS Duration

integer

C0429025 (UMLS CUI [1])

Uncorrected QT Interval

Item

Uncorrected QT Interval

integer

C1287082 (UMLS CUI [1])

QTc Interval

Item

QTc Interval

integer

C0489625 (UMLS CUI [1])

Method of QTc Calculation

Item

Method of QTc Calculation

integer

C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])

Method of QTc Calculation

Code List

Method of QTc Calculation

CL Item

Machine (1)

CL Item

Manual (2)

Result of the ECG

Item

Result of the ECG

integer

C0438154 (UMLS CUI [1])

Result of the ECG

Code List

Result of the ECG

CL Item

Normal (1)

CL Item

Abnormal - Not clinically significant (2)

CL Item

Abnormal - Clinically significant (complete the ECG abnormality form for all clinically signiﬁcant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)

CL Item

No result (not available) (4)

Electroniclly Transferred Lab Data - Dosing Date and Time

Item Group

Electronically Transferred Lab Data - Dosing Date and Time

C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
C0040223 (UMLS CUI-5)

Electronically Transferred Lab Data - Dosing Date and Time

Item

Electronically Transferred Lab Data - Dosing Date and Time

datetime

C0745590 (UMLS CUI [1,1])
C1705822 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])

Electronically Transerred Lab Data

Item Group

Electronically Transerred Lab Data

C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)

Haematology Date and time sample taken

Item

Haematology Date and time sample taken

datetime

C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Haematology sample not taken

Item

Haematology sample not taken

integer

C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

Haematology sample not taken

Code List

Haematology sample not taken

CL Item

Not done (1)

Clinical Chemistry Date and time sample taken

Item

Clinical Chemistry Date and time sample taken

datetime

C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Clinical Chemistry sample not taken

Item

Clinical Chemistry sample not taken

integer

C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

Clinical Chemistry sample not taken

Code List

Clinical Chemistry sample not taken

CL Item

Not done (1)

Serum Prolactin Date and time sample taken

Item

Serum Prolactin Date and time sample taken

datetime

C0373706 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Serum Prolactin sample not taken

Item

Serum Prolactin sample not taken

integer

C0373706 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

Serum Prolactin sample not taken

Code List

Serum Prolactin sample not taken

CL Item

Not done (1)

TSH Date and time sample taken

Item

TSH Date and time sample taken

datetime

C0202230 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

TSH sample not taken

Item

TSH sample not taken

integer

C0202230 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

TSH sample not taken

Code List

TSH sample not taken

CL Item

Not done (1)

Testosterone Date and time sample taken

Item

Testosterone Date and time sample taken

datetime

C0039601 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])

Testosterone sample not taken

Item

Testosterone sample not taken

integer

C0039601 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

Testosterone sample not taken

Code List

Testosterone sample not taken

CL Item

Not done (1)

Urinalysis Dipstick Details

Item Group

Urinalysis Dipstick Details

C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0439565 (UMLS CUI-3)

Urinalysis Date and time sample taken

Item

Urinalysis Date and time sample taken

datetime

C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])

Urinalysis Sample not taken

Item

Urinalysis Sample not taken

integer

C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

Urinalysis Sample not taken

Code List

Urinalysis Sample not taken

CL Item

Not Done (1)

Urinalysis Dipstick - pH

Item

Urinalysis Dipstick - pH

integer

C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])

Urinalysis Dipstick - pH

Code List

Urinalysis Dipstick - pH

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Dipstick - pH Numeric Result

Item

Urinalysis Dipstick - pHN umeric Result

float

C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])

Urinalysis Dipstick - pH Character Result

Item

Urinalysis Dipstick - pH Character Result

text

C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Urinalysis Dipstick - Specific Gravity

Item

Urinalysis Dipstick - Specific Gravity

integer

C0430383 (UMLS CUI [1])

Urinalysis Dipstick - Specific Gravity

Code List

Urinalysis Dipstick - Specific Gravity

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Dipstick - Specific Gravitiy Numeric Result

Item

Urinalysis Dipstick - Specific Gravitiy Numeric Result

float

C0430383 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])

Urinalysis Dipstick - Specific Gravitiy Character Result

Item

Urinalysis Dipstick - Specific Gravitiy Character Result

text

C0430383 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])

Urinalysis Dipstick - Protein

Item

Urinalysis Dipstick - Protein

integer

C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])

Urinalysis Dipstick - Protein

Code List

Urinalysis Dipstick - Protein

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Dipstick - Protein Numeric Result

Item

Urinalysis Dipstick - Protein Numeric Result

float

C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])

Urinalysis Dipstick - Protein Character Result

Item

Urinalysis Dipstick - Protein Character Result

text

C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Urinalysis Dipstick - Glucose

Item

Urinalysis Dipstick - Glucose

integer

C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])

Urinalysis Dipstick - Glucose

Code List

Urinalysis Dipstick - Glucose

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Dipstick - Glucose Numeric Result

Item

Urinalysis Dipstick - Glucose Numeric Result

float

C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])

Urinalysis Dipstick - Glucose Character Result

Item

Urinalysis Dipstick - Glucose Character Result

text

C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Urinalysis Dipstick - Ketones

Item

Urinalysis Dipstick - Ketones

integer

C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])

Urinalysis Dipstick - Ketones

Code List

Urinalysis Dipstick - Ketones

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Dipstick - Ketones Numeric Result

Item

Urinalysis Dipstick - Ketones Numeric Result

float

C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])

Urinalysis Dipstick - Ketones Character Result

Item

Urinalysis Dipstick - Ketones Character Result

text

C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Urinalysis Dipstick - RBC

Item

Urinalysis Dipstick - RBC

integer

C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])

Urinalysis Dipstick - RBC

Code List

Urinalysis Dipstick - RBC

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Dipstick - RBC Numeric Result

Item

Urinalysis Dipstick - RBC Numeric Result

float

C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])

Urinalysis Dipstick - RBC Character Result

Item

Urinalysis Dipstick - RBC Character Result

text

C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Urinalysis Dipstick - WBC

Item

Urinalysis Dipstick - WBC

integer

C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])

Urinalysis Dipstick - WBC

Code List

Urinalysis Dipstick - WBC

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Dipstick - WBC Numeric Result

Item

Urinalysis Dipstick - WBC Numeric Result

float

C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])

Urinalysis Dipstick - WBC Character Result

Item

Urinalysis Dipstick - WBC Character Result

text

C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Result of dipstick

Item

Result of dipstick

text

C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])

Result of dipstick

Code List

Result of dipstick

CL Item

No result (NR)

CL Item

Negative (NEG)

CL Item

Positive (POS)

If positive urine dipstick result, was sedimentary microscopy performed?

Item

If positive urine dipstick result, was sedimentary microscopy performed?

boolean

C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0430397 (UMLS CUI [2,1])
C2700128 (UMLS CUI [2,2])

Urinalysis - Microscopy Details

Item Group

Urinalysis - Microscopy Details

C0430397 (UMLS CUI-1)

Urinalysis Microscopy - Date and time sample taken

Item

Urinalysis Microscopy - Date and time sample taken

datetime

C0430397 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])

Urinalysis Microscopy - White blood cells

Item

Urinalysis Microscopy - White blood cells

integer

C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])

Urinalysis Microscopy - White blood cells

Code List

Urinalysis Microscopy - White blood cells

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Microscopy - White blood cells Numeric Result

Item

Urinalysis Microscopy - White blood cells Numeric Result

float

C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])

Urinalysis Microscopy - White blood cells Character Result

Item

Urinalysis Microscopy - White blood cells Character Result

text

C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Urinalysis Microscopy - Red blood cells

Item

Urinalysis Microscopy - Red blood cells

integer

C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])

Urinalysis Microscopy - Red blood cells

Code List

Urinalysis Microscopy - Red blood cells

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Microscopy - Red blood cells Numeric Result

Item

Urinalysis Microscopy - Red blood cells Numeric Result

float

C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])

Urinalysis Microscopy - Red blood cells Character Result

Item

Urinalysis Microscopy - Red blood cells Character Result

text

C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Urinalysis Microscopy - Hyaline casts

Item

Urinalysis Microscopy - Hyaline casts

text

C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])

Urinalysis Microscopy - Hyaline casts

Code List

Urinalysis Microscopy - Hyaline casts

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Microscopy - Hyaline casts Numeric Result

Item

Urinalysis Microscopy - Hyaline casts Numeric Result

float

C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])

Urinalysis Microscopy - Hyaline casts Character Result

Item

Urinalysis Microscopy - Hyaline casts Character Result

text

C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Urinalysis Microscopy - Granular casts

Item

Urinalysis Microscopy - Granular casts

integer

C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])

Urinalysis Microscopy - Granular casts

Code List

Urinalysis Microscopy - Granular casts

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Microscopy - Granular casts Numeric Result

Item

Urinalysis Microscopy - Granular casts Numeric Result

float

C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])

Urinalysis Microscopy - Granular casts Character Result

Item

Urinalysis Microscopy - Granular casts Character Result

text

C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Urinalysis Microscopy - Cellular casts

Item

Urinalysis Microscopy - Cellular casts

integer

C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])

Urinalysis Microscopy - Cellular casts

Code List

Urinalysis Microscopy - Cellular casts

CL Item

Numeric result (1)

CL Item

Character result (2)

CL Item

No result (3)

Urinalysis Microscopy - Cellular casts Numeric Result

Item

Urinalysis Microscopy - Cellular casts Numeric Result

float

C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])

Urinalysis Microscopy - Cellular casts Character Result

Item

Urinalysis Microscopy - Cellular casts Character Result

text

C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])

Study Conclusion

Item Group

Study Conclusion

C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)

Date of last contact

Item

Date of last contact

date

C0805839 (UMLS CUI [1])

Was the subject withdrawn from the study?

Item

Was the subject withdrawn from the study?

boolean

C0422727 (UMLS CUI [1])

Date of decision to withdraw

Item

If the subject withdrawn from the study, record Date of decision to withdraw.

date

C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])

Primary Reason for Withdrawal

Item

If the subject withdrawn from the study, record primary Reason for Withdrawal.

integer

Primary Reason for Withdrawal

Code List

If the subject withdrawn from the study, record primary Reason for Withdrawal.

CL Item

Adverse Event (1)

CL Item

Record detaiis on the Non-Serious Adverse Events or Serious Adverse (1)

CL Item

Events forrns as appropriate. (2)

CL Item

Protocol deviation (3)

CL Item

Study closed/terminated (4)

CL Item

Lost to Follow-up (5)

CL Item

Withdrew consent (6)

Case book ready for signature

Item

Case book ready for signature

text

C1519316 (UMLS CUI [1])

Case book ready for signature

Code List

Case book ready for signature

CL Item

Yes (Y)

Pregnancy Information

Item Group

Pregnancy Information

C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)

Did a female partner of the male subject become pregnant during the study?

Item

Did a female partner of the male subject become pregnant during the study?

text

C0919624 (UMLS CUI [1])

Did a female partner of the male subject become pregnant during the study?

Code List

Did a female partner of the male subject become pregnant during the study?

CL Item

Yes (Y)

CL Item

No (N)

CL Item

Not Applicable (X)

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Model Commentaren :

Itemgroep Commentaren voor :

Item Commentaren voor :

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957

Follow-up - Vital Signs; 12-Lead ECG; Electronically Transferred Lab Data; Urinalysis; Study Conclusion; Pregnancy Information

Beschrijving

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Maateenheden

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Beschrijving

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Maateenheden

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Beschrijving

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Maateenheden

Alias

Beschrijving

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Maateenheden

Alias

Beschrijving

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Beschrijving

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Beschrijving

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Maateenheden

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Beschrijving

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Maateenheden

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Beschrijving

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Beschrijving

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Beschrijving

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Beschrijving

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Maateenheden

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Beschrijving

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Beschrijving

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Maateenheden