ID

42084

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 end of study/ end of treatment. Complete this Form when the subject permanently stops the investigational product (IP). If the subject decided to withdraw consent and stop participation in the study, also complete the End of Study Form. If the subject decided to permanently stop the investigational product but will be followed for disease progression or survival per protocol, do not complete the End of Study Form until follow-up is complete.

Link

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

Keywords

Versions (1)
  1. 3/30/21 3/30/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 30, 2021

DOI

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License

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

English

Investigational product discontinuation

1 forms  
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
Investigational Product Discontinuation
Description

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Give primary reason Investigational Product was permanently stopped
Description

Select "Adverse event", if the subject has an adverse event due to any cause other than disease progression and the investigational product is permanently stopped due to the adverse event or if the subject died due to any cause other than disease progression. Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Select "investigator discretion" only if the subject permanently stops the IP at the investigator's discretion and none of the other primary reasons apply. Select "Decision by subject or proxy" only if the subject decided to permanently stop the IP and none of the other primary reasons apply.

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1549995
If investigator discretion, please specify:
Description

Investigational product discontinuation, specification investigator discretion

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008961
UMLS CUI [1,4]
C0022423
If decision by subject or proxy, please specify:
Description

Investigational product discontinuation, specification decision by subject or proxy

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0679006
UMLS CUI [1,4]
C0681850
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0457454
UMLS CUI [2,3]
C0679006
UMLS CUI [2,4]
C0600420
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Similar models

Investigational product discontinuation

1 forms
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
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Item
Give primary reason Investigational Product was permanently stopped
integer
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
Investigational product discontinuation, primary reason
Code List
Give primary reason Investigational Product was permanently stopped
CL Item
disease progression (including death due to disease progression) (91)
CL Item
completed scheduled treatment (92)
CL Item
adverse event (1)
CL Item
protocol deviation (3)
CL Item
study closed/terminated  (5)
CL Item
lost to follow-up (6)
CL Item
investigator discretion (7)
CL Item
Decision by subject or proxy (8)
Investigational product discontinuation, specification investigator discretion
Item
If investigator discretion, please specify:
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
Investigational product discontinuation, specification decision by subject or proxy
Item
If decision by subject or proxy, please specify:
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,4])
C0304229 (UMLS CUI [2,1])
C0457454 (UMLS CUI [2,2])
C0679006 (UMLS CUI [2,3])
C0600420 (UMLS CUI [2,4])
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