ID
41955
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 weekly visits during the treatment cycles.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Keywords
Versions (1)
- 2/22/21 2/22/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 22, 2021
DOI
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License
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Study Treatment
- StudyEvent: ODM
Description
Pre-Medications
Alias
- UMLS CUI-1
- C0033045
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0033045
- UMLS CUI [1,2]
- C2348184
Description
Trade name preferred
Data type
text
Alias
- UMLS CUI [1,1]
- C0033045
- UMLS CUI [1,2]
- C0027365
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0033045
- UMLS CUI [1,2]
- C2826819
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0033045
- UMLS CUI [1,2]
- C0871468
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0033045
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0033045
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Description
Premedication, Total daily dose
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0033045
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Description
Premedication, Route
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0033045
Description
Premedication, Start date
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0033045
- UMLS CUI [1,2]
- C0808070
Description
Premedication ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0033045
- UMLS CUI [1,2]
- C2826666
Description
Premedication, end date
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0033045
- UMLS CUI [1,2]
- C0806020
Description
Ofatumumab Infusion Details
Alias
- UMLS CUI-1
- C1832027
- UMLS CUI-2
- C0574032
- UMLS CUI-3
- C0242482
- UMLS CUI-4
- C1522508
Description
Investigational Product Infusion
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0574032
Description
Investigational Product, infusion start date and time
Data type
partialDatetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C3897500
Description
Investigational product, infusion end date and time
Data type
partialDatetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C3899266
Description
Actual dose of Ofatumumab
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C1832027
- UMLS CUI [1,2]
- C3174092
Description
Investigational Product, total volume infused
Data type
integer
Measurement units
- ml
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0449468
Description
Investigational product, infusion interrupted or stopped?
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C1512900
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0574032
- UMLS CUI [2,3]
- C0457454
Description
Investigational product, reason for not receiving
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332155
- UMLS CUI [1,3]
- C0566251
Description
Investigational product, other reason for not receiving
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332155
- UMLS CUI [1,3]
- C0566251
- UMLS CUI [1,4]
- C0205394
Description
Infusion Vitals Details Entry
Alias
- UMLS CUI-1
- C1832027
- UMLS CUI-2
- C0574032
- UMLS CUI-3
- C0518766
- UMLS CUI-4
- C1522508
Description
Start time of Infusion vitals
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C1301880
- UMLS CUI [1,3]
- C0518766
Description
Change in rate of infusion
Data type
text
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0443172
Description
Rate of infusion
Data type
integer
Measurement units
- ml/hr
Alias
- UMLS CUI [1]
- C2964135
Description
Blood pressure assessed
Data type
text
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C1516048
Description
Systolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate assessed
Data type
integer
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C1516048
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Treatment Confirmation
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Description
Correct treatment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
Description
Treatment wrong
Data type
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C3827420
Similar models
Study Treatment
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C2348184 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0574032 (UMLS CUI-2)
C0242482 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
C0574032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
C3897500 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C3899266 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C0457454 (UMLS CUI [2,3])
C0332155 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0332155 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0574032 (UMLS CUI-2)
C0518766 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
C1301880 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
C0750484 (UMLS CUI-2)
C2349182 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,2])