ID
42547
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 whenever/if blood products, blood supportive care products or other concomitant medication is administered during study.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Keywords
Versions (1)
- 8/25/21 8/25/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 25, 2021
DOI
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License
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Blood products, blood supportive care and concomitant medication
- StudyEvent: ODM
Description
Blood Products and Blood Supportive Care Products
Alias
- UMLS CUI-1
- C0456388
- UMLS CUI-2
- C0018938
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0456388
- UMLS CUI [1,2]
- C2348184
- UMLS CUI [2,1]
- C0018938
- UMLS CUI [2,2]
- C2348184
Description
Blood Products and Blood Supportive Care Products
Data type
text
Alias
- UMLS CUI [1]
- C0456388
- UMLS CUI [2]
- C0018938
Description
Other Blood Products, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0456388
- UMLS CUI [1,3]
- C1521902
Description
Other Blood Supportive Care Products, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0018938
- UMLS CUI [1,3]
- C1521902
Description
Blood Products and Blood Supportive Care Products, Cumulative Dose
Data type
text
Alias
- UMLS CUI [1,1]
- C0456388
- UMLS CUI [1,2]
- C2986497
- UMLS CUI [2,1]
- C0018938
- UMLS CUI [2,2]
- C2986497
Description
Blood Products and Blood Supportive Care Products, Units
Data type
text
Alias
- UMLS CUI [1,1]
- C0456388
- UMLS CUI [1,2]
- C1519795
- UMLS CUI [2,1]
- C0018938
- UMLS CUI [2,2]
- C1519795
Description
Blood Products and Blood Supportive Care Products, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0456388
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0018938
- UMLS CUI [2,2]
- C0808070
Description
Blood Products and Blood Supportive Care Products, Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0456388
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0018938
- UMLS CUI [2,2]
- C0806020
Description
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Description
(Trade Name preferred)
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2826819
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0871468
- UMLS CUI [1,4]
- C2347796
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1516698
- UMLS CUI [1,4]
- C0805701
- UMLS CUI [1,5]
- C2347796
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Description
Concomitant Medications, Total Daily Dose
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Description
Concomitant Medications, Units
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
Description
Concomitant Medications, Route
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013153
Description
Concomitant medications, Reason for Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3146298
Description
Concomitant Medication, Taken prior to Study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2603343
- UMLS CUI [1,3]
- C1883727
- UMLS CUI [1,4]
- C0332152
Description
Concomitant Medication, Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant Medication, ongoing
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Concomitant Medication, not ongoing
Data type
date
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C1298908
- UMLS CUI [1,3]
- C1521902
Similar models
Blood products, blood supportive care and concomitant medication
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0018938 (UMLS CUI-2)
C2348184 (UMLS CUI [1,2])
C0018938 (UMLS CUI [2,1])
C2348184 (UMLS CUI [2,2])
C0018938 (UMLS CUI [2])
C0456388 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0018938 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C0018938 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C1519795 (UMLS CUI [1,2])
C0018938 (UMLS CUI [2,1])
C1519795 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0018938 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C0018938 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C2348184 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
C2347796 (UMLS CUI [1,4])
C0013227 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C1298908 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])