ID
44786
Description
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
Keywords
Versions (1)
- 11/26/21 11/26/21 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
November 26, 2021
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Vital Signs
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C0178602
Description
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).
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0518766
Description
This item should be filled out at the Screening Visit.
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
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.
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
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.
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
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.
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
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.
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
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.
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
[hidden] This item should be filled in for all 4 weeks of the two cycles (once per visit).
Data type
text
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0444686
Similar models
Vital Signs
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0518766 (UMLS CUI [1,2])
C0444686 (UMLS CUI [1,2])