ID

44786

Descrição

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the Screening Visit, the Cycle 1 week 1, 2, 3 and 4 visits, Cycle 2 week 1, 2, 3 and 4 visits and for unscheduled visits. Note: Not all items are required for all of these visits.

Link

https://clinicaltrials.gov/ct2/show/NCT00811733

Palavras-chave

Versões (1)
  1. 26/11/2021 26/11/2021 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

26 de novembro de 2021

DOI

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Licença

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Inglês

Vital Signs

1 Formulários  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Descrição

date of visit/assessment

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
subject number
Descrição

subject ID

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
visit type
Descrição

visit type

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing date/time
Descrição

This item should be filled in for all 4 weeks of the two cycles (once per visit). Item is read-only.

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Vital Signs
Descrição

Vital Signs

Alias
UMLS CUI-1
C0518766
Time relative to dosing
Descrição

This item should be filled in for all 4 weeks of both cycles. Collect at each 8 time points values for both before and after infusion.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C0178602
Actual date/time
Descrição

This item should be filled in for all 4 weeks of the two cycles for both pre- and post-infusion, as well as in case of unscheduled measurements (for the latter not required).

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0518766
Height
Descrição

This item should be filled out at the Screening Visit.

Tipo de dados

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descrição

This item should be filled out at the Screening Visit, pre-infusion for all 4 weeks of both cycles and in case of any unscheduled measurements.

Tipo de dados

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood pressure
Descrição

This item should be filled in for screening, all 4 weeks of the two cycles for both pre- and post-infusion, as well as in case of unscheduled measurements.

Tipo de dados

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descrição

This item should be filled in for screening, all 4 weeks of the two cycles for both pre- and post-infusion, as well as in case of unscheduled measurements.

Tipo de dados

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descrição

This item should be filled in for screening, all 4 weeks of the two cycles for both pre- and post-infusion, as well as in case of unscheduled measurements.

Tipo de dados

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Descrição

This item should be filled in for screening, all 4 weeks of the two cycles for both pre- and post-infusion, as well as in case of unscheduled measurements.

Tipo de dados

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Calculated Subject position
Descrição

[hidden] This item should be filled in for all 4 weeks of the two cycles (once per visit).

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0444686
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Similar models

Vital Signs

1 Formulários
  1. StudyEvent: ODM
    1. Vital Signs
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit/assessment
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
Item
visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
Screening visit (1)
CL Item
Cycle 1 week 1 (2)
CL Item
Cycle 1 week 2 (3)
CL Item
Cycle 1 week 3 (4)
CL Item
Cycle 1 week 4 (5)
CL Item
Cycle 2 week 1 (6)
CL Item
Cycle 2 week 2 (7)
CL Item
Cycle 2 week 3 (8)
CL Item
Cycle 2 week 4 (9)
CL Item
unscheduled visit (10)
Dosing date/time
Item
Dosing date/time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Time relative to dosing
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Vital signs time relative to dosing
Code List
Time relative to dosing
CL Item
Pre-Infusion (1)
CL Item
Post-Infusion (2)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Calculated Subject position
Item
Calculated Subject position
text
C1262869 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
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