ID

41943

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. All of these Itemgroups have to be filled out at the second, third and forth weekly visits during treatment cycles. The liver events assessment Itemgroup should also be filled out at the first weekly visit during treatment cycles, as well as the cycle observation visits. The liver events assessment 2 Itemgroup should additionally be filled out at the cycle observation visits as well.

Link

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

Keywords

Versions (1)
  1. 2/19/21 2/19/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 19, 2021

DOI

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License

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

English

Liver Events Assessment

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
visit type
Description

visit type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Description

Protocol defined liver chemistry event for the lab samples collected

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C0877248
UMLS CUI [1,5]
C0200345
If yes, specify type of liver chemistry event
Description

If Yes and type of liver chemistry event is Liver Event (Interruption), interrupt investigational product, complete date interrupted on Investigational Product Form and contact GSK within 24 hours of occurrence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. * Obtain tests as per protocol * Blood sample for pharmacokinetic (PK) analysis of ofatumumab, obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug) * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours) If Yes and type of liver chemistry event is Liver Monitoring, obtain tests as per protocol. If Yes and type of liver chemistry event is Liver Event (Stopping), stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurrence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. * Blood sample for pharmacokinetic (PK) analysis of ofatumumab, obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug) * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours)

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C2348235
If Yes is marked for either Liver Event Interruption Criteria or Liver Event Stopping Criteria, go to LIVER EVENT form, enter a DOV and complete the Liver Event forms.
Description

[read-only]

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C1512900
UMLS CUI [1,5]
C0243161
UMLS CUI [2,1]
C0008000
UMLS CUI [2,2]
C0023884
UMLS CUI [2,3]
C0877248
UMLS CUI [2,4]
C2746065
UMLS CUI [2,5]
C0243161
Liver IP Rechallenge Status
Description

Liver IP Rechallenge Status

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
UMLS CUI-3
C2347900
UMLS CUI-4
C0449438
Has the subject been re-challenged with Investigational Product following a Liver Event?
Description

This item has to be filled out at the 2, 3 and 4 week visit for cycle 1 and cycle 2 of therapy.

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2347900
UMLS CUI [1,4]
C0304229
Liver Events Assessment 2
Description

Liver Events Assessment 2

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Description

Note: If a subject has been monitored for 4 weeks and continues to meet liver chemistry monitoring criteria, subject must be identified as a liver event. This Itemgroup has to be filled out at the 2, 3 and 4 week visit of cycle 1 and cycle 2 of therapy as well as for the observation visits of the treatment cycles.

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C0877248
UMLS CUI [1,5]
C0200345
If yes, specify type of liver chemistry event
Description

If Yes and type of liver chemistry event is Liver Event (Interruption), interrupt investigational product, complete date interrupted on Investigational Product Form and contact GSK within 24 hours of occurrence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. * Blood sample for pharmacokinetic (PK) analysis of ofatumumab, obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug) * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours) If Yes and type of liver chemistry event is Liver Monitoring, obtain tests as per protocol. If Yes and type of liver chemistry event is Liver Event (Stopping), stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurrence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. *Obtain tests as per protocol * Blood sample for pharmacokinetic (PK) analysis of ofatumumab, obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug) * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours)

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C2348235
If Yes is marked for either Liver Event Interruption Criteria or Liver Event Stopping Criteria, go to LIVER LOG form, enter a DOV and complete the Liver Event forms.
Description

[read-only]

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C1512900
UMLS CUI [1,5]
C0243161
UMLS CUI [2,1]
C0008000
UMLS CUI [2,2]
C0023884
UMLS CUI [2,3]
C2746065
UMLS CUI [2,4]
C0243161
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Similar models

Liver Events Assessment

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
visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
Cycle 1 week 1  (1)
CL Item
Cycle 1 week 2 (2)
CL Item
Cycle 1 week 3 (3)
CL Item
Cycle 1 week 4  (4)
CL Item
Cycle 1 observation visit (5)
CL Item
Cycle 2 week 1 (6)
CL Item
Cycle 2 week 2 (7)
CL Item
Cycle 2 week 3 (8)
CL Item
Cycle 2 week 4 (9)
CL Item
Cycle 2 observation visit (10)
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Protocol defined liver chemistry event for the lab samples collected
Item
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
boolean
C2348563 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,5])
Item
If yes, specify type of liver chemistry event
integer
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Liver chemistry event, specification
Code List
If yes, specify type of liver chemistry event
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria) (1)
CL Item
Liver Event Interruption Criteria (subject has met protocol defined liver event interruption criteria) (2)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria) (3)
Liver chemistry event meeting interruption or stopping criteria
Item
If Yes is marked for either Liver Event Interruption Criteria or Liver Event Stopping Criteria, go to LIVER EVENT form, enter a DOV and complete the Liver Event forms.
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])
C0008000 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0877248 (UMLS CUI [2,3])
C2746065 (UMLS CUI [2,4])
C0243161 (UMLS CUI [2,5])
Item Group
Liver IP Rechallenge Status
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C2347900 (UMLS CUI-3)
C0449438 (UMLS CUI-4)
Rechallenge with Investigational Product after Liver Event
Item
Has the subject been re-challenged with Investigational Product following a Liver Event?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2347900 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Item Group
Liver Events Assessment 2
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Protocol defined liver chemistry event for the lab samples collected
Item
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
boolean
C2348563 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,5])
Item
If yes, specify type of liver chemistry event
integer
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Liver chemistry event, specification
Code List
If yes, specify type of liver chemistry event
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria) (1)
CL Item
Liver Event Interruption Criteria (subject has met protocol defined liver event interruption criteria) (2)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria or has been monitored for {insert protocol specific time} and continues to meet liver chemistry event criteria) (3)
Liver chemistry event meeting interruption or stopping criteria
Item
If Yes is marked for either Liver Event Interruption Criteria or Liver Event Stopping Criteria, go to LIVER LOG form, enter a DOV and complete the Liver Event forms.
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])
C0008000 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C2746065 (UMLS CUI [2,3])
C0243161 (UMLS CUI [2,4])
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