ID
42555
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00811733
Nyckelord
Versioner (1)
- 2021-08-30 2021-08-30 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
30 augusti 2021
DOI
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Licens
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Liver Events
- StudyEvent: ODM
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Alias
- UMLS CUI-1
- C0023901
Beskrivning
Liver events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beskrivning
Subject age
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348575
Beskrivning
If Yes, ensure Pregnancy Notification Form has been completed.
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
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)
Datatyp
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
Beskrivning
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatyp
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
Beskrivning
If Yes, complete Liver Biopsy form. [hidden]
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0193388
Beskrivning
If Yes, record on the appropriate Concomitant Medication form.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0002346
- UMLS CUI [2]
- C0242295
- UMLS CUI [3]
- C0281875
- UMLS CUI [4]
- C1360419
- UMLS CUI [5]
- C4053461
Beskrivning
Recent fasting or dietary changes
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0015663
- UMLS CUI [2,2]
- C0332185
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2826267
Beskrivning
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0031328
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beskrivning
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.
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beskrivning
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.
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Beskrivning
Acute Viral Hepatitis A
Datatyp
text
Alias
- UMLS CUI [1]
- C0276434
Beskrivning
Chronic Hepatitis B
Datatyp
text
Alias
- UMLS CUI [1]
- C0524909
Beskrivning
Chronic Hepatitis C
Datatyp
text
Alias
- UMLS CUI [1]
- C0524910
Beskrivning
Cytomegalovirus Hepatitis
Datatyp
text
Alias
- UMLS CUI [1]
- C0276252
Beskrivning
Epstein Barr Virus Infectious Mononucleosis
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0021345
- UMLS CUI [1,2]
- C0014644
Beskrivning
Herpes Simplex Hepatitis
Datatyp
text
Alias
- UMLS CUI [1]
- C1963747
Beskrivning
Alcoholic Liver Disease
Datatyp
text
Alias
- UMLS CUI [1]
- C0023896
Beskrivning
Non-alcoholic Steatohepatitis
Datatyp
text
Alias
- UMLS CUI [1]
- C3241937
Beskrivning
Fatty Liver
Datatyp
text
Alias
- UMLS CUI [1]
- C0015695
Beskrivning
Hepatic Cirrhosis
Datatyp
text
Alias
- UMLS CUI [1]
- C0023890
Beskrivning
Hemochromatosis
Datatyp
text
Alias
- UMLS CUI [1]
- C0018995
Beskrivning
Autoimmune Hepatitis
Datatyp
text
Alias
- UMLS CUI [1]
- C0241910
Beskrivning
Gallbladder disease
Datatyp
text
Alias
- UMLS CUI [1]
- C0016977
Beskrivning
Liver metastases
Datatyp
text
Alias
- UMLS CUI [1]
- C0494165
Beskrivning
Hepatitis E IgM antibody
Datatyp
text
Alias
- UMLS CUI [1]
- C3272944
Beskrivning
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beskrivning
Other liver disease conditions Entry
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Specific condition
Datatyp
text
Alias
- UMLS CUI [1]
- C0023895
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2826923
- UMLS CUI [1,2]
- C0023895
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C1140263
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Liver disease, Status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0449438
- UMLS CUI [1,2]
- C0023895
Beskrivning
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beskrivning
Drug allergies
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0013227
Beskrivning
Rheumatoid Arthritis
Datatyp
text
Alias
- UMLS CUI [1]
- C0003873
Beskrivning
Psoriasis
Datatyp
text
Alias
- UMLS CUI [1]
- C0033860
Beskrivning
Thyroid Disease
Datatyp
text
Alias
- UMLS CUI [1]
- C0040128
Beskrivning
Inflammatory Bowel Disease
Datatyp
text
Alias
- UMLS CUI [1]
- C0021390
Beskrivning
Lupus
Datatyp
text
Alias
- UMLS CUI [1]
- C0409974
Beskrivning
Sjogrens Syndrome
Datatyp
text
Alias
- UMLS CUI [1]
- C1527336
Beskrivning
Vitiligo
Datatyp
text
Alias
- UMLS CUI [1]
- C0042900
Beskrivning
Alcohol intake (Liver alcohol)
Alias
- UMLS CUI-1
- C0001948
Beskrivning
Alcohol consumption
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
Average number of units per week
Datatyp
integer
Måttenheter
- units of alcohol per week
Alias
- UMLS CUI [1,1]
- C0560579
- UMLS CUI [1,2]
- C1510992
Beskrivning
[hidden]
Datatyp
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])