ID

41870

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.

Link

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

Keywords

Versions (1)
  1. 2/8/21 2/8/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 8, 2021

DOI

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License

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

English

Prior WM Therapy

1 forms  
  1. StudyEvent: ODM
    1. Prior WM Therapy
Administrative Data
Description

Administrative Data

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

date of visit/assessment

Data type

date

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

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Previous WM Treatment Status
Description

Previous WM Treatment Status

Alias
UMLS CUI-1
C0205156
UMLS CUI-2
C0749659
UMLS CUI-3
C0024419
Has the subject previously received treatment for WM?
Description

Waldenstrom Macroglobulinemia, previous treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
Prior Waldenstrom's Macroglobulinemia Therapy
Description

Prior Waldenstrom's Macroglobulinemia Therapy

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0024419
Sequence number
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C2348184
Modified reported term
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C2826819
GSK Drug synonym
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0871468
GSK Drug collection code
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C1516698
UMLS CUI [1,5]
C0805701
Failed coding
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C0231175
Regimen sequence
Description

Prior therapy for WM, Regimen sequence

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C1276413
UMLS CUI [1,4]
C2348184
Therapy type
Description

Prior therapy for WM, therapy type

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C0332307
Number of cycles/doses
Description

Prior therapy for WM, number of cycles/doses

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C0449788
UMLS CUI [1,4]
C1302181
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0024419
UMLS CUI [2,3]
C0449788
UMLS CUI [2,4]
C0178602
Units
Description

Prior therapy for WM, Units

Data type

integer

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C0439148
Cumulative dose
Description

Prior therapy for WM, cumulative dose

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C2986497
Dose units
Description

Prior therapy for WM, dose units

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C1519795
Intent
Description

Prior therapy for WM, intent

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C1283828
Start date
Description

Prior therapy for WM, start date

Data type

date

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C0808070
Stop date
Description

Prior therapy for WM, end date

Data type

date

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C0806020
Best response
Description

Prior therapy for WM, best response

Data type

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C2986560
Duration of response
Description

Prior therapy for WM, duration of response

Data type

integer

Measurement units
  • weeks
Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C0237585
weeks
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Similar models

Prior WM Therapy

1 forms
  1. StudyEvent: ODM
    1. Prior WM Therapy
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 Group
Previous WM Treatment Status
C0205156 (UMLS CUI-1)
C0749659 (UMLS CUI-2)
C0024419 (UMLS CUI-3)
Waldenstrom Macroglobulinemia, previous treatment
Item
Has the subject previously received treatment for WM?
boolean
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
Item Group
Prior Waldenstrom's Macroglobulinemia Therapy
C1514463 (UMLS CUI-1)
C0024419 (UMLS CUI-2)
Prior therapy for WM, sequence number
Item
Sequence number
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Prior therapy for WM, Modified reported term
Item
Modified reported term
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,3])
Prior therapy for WM, GSK Drug synonym
Item
GSK Drug synonym
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0871468 (UMLS CUI [1,4])
Prior therapy for WM, GSK Drug collection code
Item
GSK Drug collection code
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,4])
C0805701 (UMLS CUI [1,5])
Prior therapy for WM, failed coding
Item
Failed coding
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Prior therapy for WM, Regimen sequence
Item
Regimen sequence
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C1276413 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Item
Therapy type
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Prior therapy for WM, therapy type
Code List
Therapy type
CL Item
biologic therapy (antibodies, cytokines) (B)
CL Item
Chemotherapy (cytotoxics, non-cytotoxics) (C)
CL Item
Hormonal therapy (H)
CL Item
Immunotherapy (I)
CL Item
Unknown (U)
Prior therapy for WM, number of cycles/doses
Item
Number of cycles/doses
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C1302181 (UMLS CUI [1,4])
C1514463 (UMLS CUI [2,1])
C0024419 (UMLS CUI [2,2])
C0449788 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
Item
Units
integer
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Prior therapy for WM, Units
Code List
Units
CL Item
cycles (1)
CL Item
doses (2)
Prior therapy for WM, cumulative dose
Item
Cumulative dose
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
Item
Dose units
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Prior therapy for WM, dose units
Code List
Dose units
CL Item
Actuation  (ACTU)
CL Item
Ampoule (AMP)
CL Item
Apllication (APP)
CL Item
Area under curve (AUC)
CL Item
Bottle (BOT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Cup (CUP)
CL Item
Finger tip unit (FTU)
CL Item
Gamma per kilogram per minute (GA/KG/MIN)
CL Item
Gram (G)
CL Item
Drops (GTT)
CL Item
100 International units/ml (100IU/ML)
CL Item
Inhalation (INH)
CL Item
International units (IU)
CL Item
International units per kilogram (IU/KG)
CL Item
International units per kilogram per hour  (IU/KG/HR)
CL Item
International units per millilitre (IU/ML)
CL Item
litre (L)
CL Item
lozenge (LOZ)
CL Item
Litre per minute (L/MIN)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Mega becquerels (MBq) (MBQ)
CL Item
Microgram (MCG) (MCG)
CL Item
Micrograms per hour (MCG/HR)
CL Item
Micrograms per kilogram  (MCG/KG)
CL Item
Micrograms per kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Micrograms per millilitre (MCG/ML)
CL Item
Millicurie (MCI)
CL Item
Microlitre (MCL)
CL Item
Milliequivalent (MEQ)
CL Item
Milliequivalent per 24 hours (MEQ/24HR)
CL Item
Milligram (MG)
CL Item
Milligram per day (MG/DAY)
CL Item
Milligram per hour (MG/HR)
CL Item
Milligram per kilogram per hour (MG/KG/HR)
CL Item
Milligram per kilogram per minute (MG/KG/MIN)
CL Item
Milligram per metre squared (MG/M2)
CL Item
Milligram per millilitre (MG/ML)
CL Item
Milligrams percent  (MG%)
CL Item
Million international units (MIU)
CL Item
Millilitre (ML)
CL Item
Millilitre per hour (ML/HR)
CL Item
Millilitre per minute (ML/MIN)
CL Item
Millimole (MMOL)
CL Item
Millimole per kilogram (MMOL/KG)
CL Item
Megaunits (MU)
CL Item
Nebule (NEB)
CL Item
Ounce (OZ)
CL Item
Patch (PATCH)
CL Item
Percent (%)
CL Item
Puff (PUFF)
CL Item
Ring (RING)
CL Item
Sachet (SACH)
CL Item
Spray (SPR)
CL Item
Suppository (SUOO)
CL Item
Tablet (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon (TSP)
CL Item
Microgram (UG) (UG)
CL Item
Units per hour (U/HR)
CL Item
Units per kilogram per minute (U/KG/MIN)
CL Item
Units per minute (U/MIN)
CL Item
Mikromoles per 24hours (UMOL/24HR)
CL Item
Units (U)
CL Item
Unknown (UNK)
CL Item
Units per gram (U/G)
CL Item
Vial (VIAL)
Item
Intent
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,3])
Prior therapy for WM, intent
Code List
Intent
CL Item
neo-adjuvant (1)
CL Item
adjuvant (2)
CL Item
advanced or metastatic  (3)
CL Item
local/regional (4)
CL Item
prophylactic (5)
CL Item
radiosensitizer (6)
CL Item
transplant (8)
CL Item
induction (10)
CL Item
consolidation (11)
CL Item
maintenance (12)
CL Item
mobilization (13)
CL Item
salvage  (14)
CL Item
not applicable (X)
Prior therapy for WM, start date
Item
Start date
date
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Prior therapy for WM, end date
Item
Stop date
date
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Best response
text
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C2986560 (UMLS CUI [1,3])
Prior therapy for WM, best response
Code List
Best response
CL Item
complete response (1)
CL Item
partial response (2)
CL Item
stable disease (3)
CL Item
progressive disease (4)
CL Item
not evaluable  (6)
CL Item
unknown (U)
CL Item
not applicable (X)
Prior therapy for WM, duration of response
Item
Duration of response
integer
C1514463 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0237585 (UMLS CUI [1,3])
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