ID
42555
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. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver events occur.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Keywords
Versions (1)
- 8/30/21 8/30/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 30, 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
- StudyEvent: ODM
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Alias
- UMLS CUI-1
- C0023901
Description
Liver events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Description
Subject age
Data type
boolean
Alias
- UMLS CUI [1]
- C2348575
Description
If Yes, ensure Pregnancy Notification Form has been completed.
Data type
text
Alias
- UMLS CUI [1]
- C0032961
Description
Diagnostic imaging tests of the liver or hepatobiliary system (i.e. liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C1711359
- UMLS CUI [3,1]
- C0023884
- UMLS CUI [3,2]
- C1456803
- UMLS CUI [4,1]
- C0023884
- UMLS CUI [4,2]
- C0040405
- UMLS CUI [5,1]
- C0023884
- UMLS CUI [5,2]
- C0024485
- UMLS CUI [6]
- C0008310
Description
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C1274040
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C1711359
- UMLS CUI [2,3]
- C1274040
Description
If Yes, complete Liver Biopsy form. [hidden]
Data type
boolean
Alias
- UMLS CUI [1]
- C0193388
Description
If Yes, record on the appropriate Concomitant Medication form.
Data type
boolean
Alias
- UMLS CUI [1]
- C0002346
- UMLS CUI [2]
- C0242295
- UMLS CUI [3]
- C0281875
- UMLS CUI [4]
- C1360419
- UMLS CUI [5]
- C4053461
Description
Recent fasting or dietary changes
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0015663
- UMLS CUI [2,2]
- C0332185
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2826267
Description
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0031328
Description
An unscheduled blood sample for pharmacokinetic (PK) analysis of ofatumumab must be obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug). PK sample should only be taken if subject is currently on ofatumumab.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Description
An unscheduled blood sample for pharmacokinetic (PK) analysis of ofatumumab must be obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug). PK sample should only be taken if subject is currently on ofatumumab.
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C0031328
- UMLS CUI [2,3]
- C0040223
Description
An unscheduled blood sample for pharmacokinetic (PK) analysis of ofatumumab must be obtained as soon as possible but no later than 5 months of last dose (approximately 5 half-lives of the drug). PK sample should only be taken if subject is currently on ofatumumab.
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1517741
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [2,1]
- C1517741
- UMLS CUI [2,2]
- C0304229
- UMLS CUI [2,3]
- C0040223
Description
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Description
Note: Only complete dates for the treatment period where the liver event occurred. If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0808070
- UMLS CUI [1,6]
- C1272460
Description
Note: Only complete dates for the treatment period where the liver event occurred. If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0808070
Description
Note: Only complete dates for the treatment period where the liver event occurred. If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0806020
- UMLS CUI [1,6]
- C1272460
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0347984
- UMLS CUI [2,3]
- C2347804
- UMLS CUI [2,4]
- C1512900
- UMLS CUI [2,5]
- C0304229
- UMLS CUI [2,6]
- C0806020
- UMLS CUI [2,7]
- C1272460
Description
Note: Only complete dates for the treatment period where the liver event occurred. If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0806020
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0347984
- UMLS CUI [2,3]
- C2347804
- UMLS CUI [2,4]
- C1512900
- UMLS CUI [2,5]
- C0806020
- UMLS CUI [2,6]
- C0304229
Description
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0808070
- UMLS CUI [1,6]
- C1272460
Description
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0808070
Description
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0806020
- UMLS CUI [1,6]
- C1272460
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0687676
- UMLS CUI [2,3]
- C0087111
- UMLS CUI [2,4]
- C1512900
- UMLS CUI [2,5]
- C0304229
- UMLS CUI [2,6]
- C0806020
- UMLS CUI [2,7]
- C1272460
Description
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0806020
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0687676
- UMLS CUI [2,3]
- C0087111
- UMLS CUI [2,4]
- C1512900
- UMLS CUI [2,5]
- C0304229
- UMLS CUI [2,6]
- C0806020
Description
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Description
Acute Viral Hepatitis A
Data type
text
Alias
- UMLS CUI [1]
- C0276434
Description
Chronic Hepatitis B
Data type
text
Alias
- UMLS CUI [1]
- C0524909
Description
Chronic Hepatitis C
Data type
text
Alias
- UMLS CUI [1]
- C0524910
Description
Cytomegalovirus Hepatitis
Data type
text
Alias
- UMLS CUI [1]
- C0276252
Description
Epstein Barr Virus Infectious Mononucleosis
Data type
text
Alias
- UMLS CUI [1,1]
- C0021345
- UMLS CUI [1,2]
- C0014644
Description
Herpes Simplex Hepatitis
Data type
text
Alias
- UMLS CUI [1]
- C1963747
Description
Alcoholic Liver Disease
Data type
text
Alias
- UMLS CUI [1]
- C0023896
Description
Non-alcoholic Steatohepatitis
Data type
text
Alias
- UMLS CUI [1]
- C3241937
Description
Fatty Liver
Data type
text
Alias
- UMLS CUI [1]
- C0015695
Description
Hepatic Cirrhosis
Data type
text
Alias
- UMLS CUI [1]
- C0023890
Description
Hemochromatosis
Data type
text
Alias
- UMLS CUI [1]
- C0018995
Description
Autoimmune Hepatitis
Data type
text
Alias
- UMLS CUI [1]
- C0241910
Description
Gallbladder disease
Data type
text
Alias
- UMLS CUI [1]
- C0016977
Description
Liver metastases
Data type
text
Alias
- UMLS CUI [1]
- C0494165
Description
Hepatitis E IgM antibody
Data type
text
Alias
- UMLS CUI [1]
- C3272944
Description
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Description
Other liver disease conditions Entry
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2348184
Description
Specific condition
Data type
text
Alias
- UMLS CUI [1]
- C0023895
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C2826923
- UMLS CUI [1,2]
- C0023895
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C1140263
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C3898442
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Liver disease, Status
Data type
text
Alias
- UMLS CUI [1,1]
- C0449438
- UMLS CUI [1,2]
- C0023895
Description
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Description
Drug allergies
Data type
text
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0013227
Description
Rheumatoid Arthritis
Data type
text
Alias
- UMLS CUI [1]
- C0003873
Description
Psoriasis
Data type
text
Alias
- UMLS CUI [1]
- C0033860
Description
Thyroid Disease
Data type
text
Alias
- UMLS CUI [1]
- C0040128
Description
Inflammatory Bowel Disease
Data type
text
Alias
- UMLS CUI [1]
- C0021390
Description
Lupus
Data type
text
Alias
- UMLS CUI [1]
- C0409974
Description
Sjogrens Syndrome
Data type
text
Alias
- UMLS CUI [1]
- C1527336
Description
Vitiligo
Data type
text
Alias
- UMLS CUI [1]
- C0042900
Description
Alcohol intake (Liver alcohol)
Alias
- UMLS CUI-1
- C0001948
Description
Alcohol consumption
Data type
boolean
Alias
- UMLS CUI [1]
- C0001948
Description
Average number of units per week
Data type
integer
Measurement units
- units of alcohol per week
Alias
- UMLS CUI [1,1]
- C0560579
- UMLS CUI [1,2]
- C1510992
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Similar models
Liver Events
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C0023884 (UMLS CUI [3,1])
C1456803 (UMLS CUI [3,2])
C0023884 (UMLS CUI [4,1])
C0040405 (UMLS CUI [4,2])
C0023884 (UMLS CUI [5,1])
C0024485 (UMLS CUI [5,2])
C0008310 (UMLS CUI [6])
C0023884 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C1274040 (UMLS CUI [2,3])
C0242295 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
C1360419 (UMLS CUI [4])
C4053461 (UMLS CUI [5])
C0332185 (UMLS CUI [1,2])
C0015663 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0031328 (UMLS CUI-2)
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C0031328 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0023884 (UMLS CUI-2)
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
C0877248 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
C0806020 (UMLS CUI [2,6])
C1272460 (UMLS CUI [2,7])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C0877248 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0806020 (UMLS CUI [2,5])
C0304229 (UMLS CUI [2,6])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C1272460 (UMLS CUI [1,6])
C0877248 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
C0806020 (UMLS CUI [2,6])
C1272460 (UMLS CUI [2,7])
C0687676 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C0877248 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1512900 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
C0806020 (UMLS CUI [2,6])
C0014644 (UMLS CUI [1,2])
C0277579 (UMLS CUI-2)
C0277579 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0023895 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C1510992 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])