ID
42555
Beschreibung
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
Stichworte
Versionen (1)
- 30.08.21 30.08.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
30. August 2021
DOI
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Lizenz
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Liver Events
- StudyEvent: ODM
Beschreibung
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Alias
- UMLS CUI-1
- C0023901
Beschreibung
Liver events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschreibung
Subject age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348575
Beschreibung
If Yes, ensure Pregnancy Notification Form has been completed.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
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)
Datentyp
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
Beschreibung
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datentyp
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
Beschreibung
If Yes, complete Liver Biopsy form. [hidden]
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0193388
Beschreibung
If Yes, record on the appropriate Concomitant Medication form.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0002346
- UMLS CUI [2]
- C0242295
- UMLS CUI [3]
- C0281875
- UMLS CUI [4]
- C1360419
- UMLS CUI [5]
- C4053461
Beschreibung
Recent fasting or dietary changes
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0015663
- UMLS CUI [2,2]
- C0332185
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C2826267
Beschreibung
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0031328
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
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.
Datentyp
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
Beschreibung
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Beschreibung
Acute Viral Hepatitis A
Datentyp
text
Alias
- UMLS CUI [1]
- C0276434
Beschreibung
Chronic Hepatitis B
Datentyp
text
Alias
- UMLS CUI [1]
- C0524909
Beschreibung
Chronic Hepatitis C
Datentyp
text
Alias
- UMLS CUI [1]
- C0524910
Beschreibung
Cytomegalovirus Hepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C0276252
Beschreibung
Epstein Barr Virus Infectious Mononucleosis
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021345
- UMLS CUI [1,2]
- C0014644
Beschreibung
Herpes Simplex Hepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C1963747
Beschreibung
Alcoholic Liver Disease
Datentyp
text
Alias
- UMLS CUI [1]
- C0023896
Beschreibung
Non-alcoholic Steatohepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C3241937
Beschreibung
Fatty Liver
Datentyp
text
Alias
- UMLS CUI [1]
- C0015695
Beschreibung
Hepatic Cirrhosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0023890
Beschreibung
Hemochromatosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0018995
Beschreibung
Autoimmune Hepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C0241910
Beschreibung
Gallbladder disease
Datentyp
text
Alias
- UMLS CUI [1]
- C0016977
Beschreibung
Liver metastases
Datentyp
text
Alias
- UMLS CUI [1]
- C0494165
Beschreibung
Hepatitis E IgM antibody
Datentyp
text
Alias
- UMLS CUI [1]
- C3272944
Beschreibung
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beschreibung
Other liver disease conditions Entry
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Specific condition
Datentyp
text
Alias
- UMLS CUI [1]
- C0023895
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826923
- UMLS CUI [1,2]
- C0023895
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C1140263
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Liver disease, Status
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0449438
- UMLS CUI [1,2]
- C0023895
Beschreibung
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschreibung
Drug allergies
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0013227
Beschreibung
Rheumatoid Arthritis
Datentyp
text
Alias
- UMLS CUI [1]
- C0003873
Beschreibung
Psoriasis
Datentyp
text
Alias
- UMLS CUI [1]
- C0033860
Beschreibung
Thyroid Disease
Datentyp
text
Alias
- UMLS CUI [1]
- C0040128
Beschreibung
Inflammatory Bowel Disease
Datentyp
text
Alias
- UMLS CUI [1]
- C0021390
Beschreibung
Lupus
Datentyp
text
Alias
- UMLS CUI [1]
- C0409974
Beschreibung
Sjogrens Syndrome
Datentyp
text
Alias
- UMLS CUI [1]
- C1527336
Beschreibung
Vitiligo
Datentyp
text
Alias
- UMLS CUI [1]
- C0042900
Beschreibung
Alcohol intake (Liver alcohol)
Alias
- UMLS CUI-1
- C0001948
Beschreibung
Alcohol consumption
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
Average number of units per week
Datentyp
integer
Maßeinheiten
- units of alcohol per week
Alias
- UMLS CUI [1,1]
- C0560579
- UMLS CUI [1,2]
- C1510992
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Ähnliche Modelle
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])