ID

41889

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. This form has to be filled out at the screening visit, the weekly visits during the cycles of treatment, the cycle observation visits, unscheduled visits, withdrawal visits and visits at the end of study/ treatment.

Link

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

Keywords

  1. 2/9/21 2/9/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 9, 2021

DOI

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License

Creative Commons BY-NC 4.0

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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Constitutional Symptoms and ECOG

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
Constitutional Symptoms
Description

Constitutional Symptoms

Alias
UMLS CUI-1
C0009812
Night sweats without signs of infection
Description

Night sweats without signs of infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0028081
UMLS CUI [1,2]
C0009450
UMLS CUI [1,3]
C0332197
Unintentional weight loss >= 10% within the previous 6 months
Description

Recent unintentional weight loss

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C2363736
Recurrent, unexplained fever of greater than 100°F for 2 weeks without signs of infection
Description

Recurrent, unexplained fever

Data type

boolean

Alias
UMLS CUI [1,1]
C2945760
UMLS CUI [1,2]
C1844662
Extreme fatigue
Description

Extreme fatigue

Data type

boolean

Alias
UMLS CUI [1,1]
C0205403
UMLS CUI [1,2]
C0015672
ECOG Performance Status Scale
Description

ECOG Performance Status Scale

Alias
UMLS CUI-1
C1520224
Total Score
Description

ECOG Performance status, total score

Data type

text

Alias
UMLS CUI [1,1]
C1520224
UMLS CUI [1,2]
C2964552

Similar models

Constitutional Symptoms and ECOG

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])
Code List
visit type
CL Item
Screening visit (A)
CL Item
Cycle 1 week 1 (B)
CL Item
Cycle 1 week 2 (C)
CL Item
Cycle 1 week 3  (D)
CL Item
Cycle 1 week 4 (E)
CL Item
Cycle 1 Observation  (F)
CL Item
unscheduled visit (G)
CL Item
Withdrawal visit (H)
CL Item
End of Study / Treatment (I)
CL Item
Cycle 2 Week 1 (J)
CL Item
Cycle 2 Week 2 (K)
CL Item
Cycle 2 Week 3 (L)
CL Item
Cycle 2 Week 4 (M)
CL Item
Cycle 2 Observation (N)
Item Group
Constitutional Symptoms
C0009812 (UMLS CUI-1)
Night sweats without signs of infection
Item
Night sweats without signs of infection
boolean
C0028081 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Recent unintentional weight loss
Item
Unintentional weight loss >= 10% within the previous 6 months
boolean
C0332185 (UMLS CUI [1,1])
C2363736 (UMLS CUI [1,2])
Recurrent, unexplained fever
Item
Recurrent, unexplained fever of greater than 100°F for 2 weeks without signs of infection
boolean
C2945760 (UMLS CUI [1,1])
C1844662 (UMLS CUI [1,2])
Extreme fatigue
Item
Extreme fatigue
boolean
C0205403 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Item Group
ECOG Performance Status Scale
C1520224 (UMLS CUI-1)
ECOG Performance status, total score
Item
Total Score
text
C1520224 (UMLS CUI [1,1])
C2964552 (UMLS CUI [1,2])

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