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)
- 2/19/21 2/19/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 19, 2021
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Liver Events Assessment
- StudyEvent: ODM
Description
Liver Events Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
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
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
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
Description
Liver IP Rechallenge Status
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C2347900
- UMLS CUI-4
- C0449438
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
Description
Liver Events Assessment 2
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
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
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
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
Similar models
Liver Events Assessment
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0008000 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,5])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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])
C0023884 (UMLS CUI-2)
C2347900 (UMLS CUI-3)
C0449438 (UMLS CUI-4)
C0877248 (UMLS CUI [1,2])
C2347900 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0008000 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,5])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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])