ID

41955

Descripción

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 weekly visits during the treatment cycles.

Link

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

Palabras clave

Versiones (1)
  1. 22/2/21 22/2/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de febrero de 2021

DOI

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Licencia

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Inglés

Study Treatment

1 formularios  
  1. StudyEvent: ODM
    1. Study Treatment
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Descripción

date of visit/assessment

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
subject number
Descripción

subject ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
visit type
Descripción

visit type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Pre-Medications
Descripción

Pre-Medications

Alias
UMLS CUI-1
C0033045
Sequence number
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C2348184
Drug name
Descripción

Trade name preferred

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C0027365
Modified reported term
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C2826819
GSK drug synonym
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C0871468
GSK drug collection code
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Total daily dose
Descripción

Premedication, Total daily dose

Tipo de datos

integer

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
mg
Route
Descripción

Premedication, Route

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0033045
Start date
Descripción

Premedication, Start date

Tipo de datos

partialDate

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C0808070
Ongoing?
Descripción

Premedication ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C2826666
If no, please specify end date.
Descripción

Premedication, end date

Tipo de datos

partialDate

Alias
UMLS CUI [1,1]
C0033045
UMLS CUI [1,2]
C0806020
Ofatumumab Infusion Details
Descripción

Ofatumumab Infusion Details

Alias
UMLS CUI-1
C1832027
UMLS CUI-2
C0574032
UMLS CUI-3
C0242482
UMLS CUI-4
C1522508
Did the subject receive Investigatonal Product?
Descripción

Investigational Product Infusion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0574032
If yes, please state start date and time
Descripción

Investigational Product, infusion start date and time

Tipo de datos

partialDatetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C3897500
If yes, please state end date and time
Descripción

Investigational product, infusion end date and time

Tipo de datos

partialDatetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C3899266
If yes, please state actual dose of Ofatumumab
Descripción

Actual dose of Ofatumumab

Tipo de datos

integer

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C1832027
UMLS CUI [1,2]
C3174092
mg
If yes, please state total volume infused
Descripción

Investigational Product, total volume infused

Tipo de datos

integer

Unidades de medida
  • ml
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0449468
ml
If yes, was the infusion interrupted or stopped?
Descripción

Investigational product, infusion interrupted or stopped?

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C1512900
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0574032
UMLS CUI [2,3]
C0457454
If the subject did not receive the investigational product, please specify the reason.
Descripción

Investigational product, reason for not receiving

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0566251
If other, please specify
Descripción

Investigational product, other reason for not receiving

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205394
Infusion Vitals Details Entry
Descripción

Infusion Vitals Details Entry

Alias
UMLS CUI-1
C1832027
UMLS CUI-2
C0574032
UMLS CUI-3
C0518766
UMLS CUI-4
C1522508
Start time
Descripción

Start time of Infusion vitals

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1301880
UMLS CUI [1,3]
C0518766
Rate of infusion
Descripción

Change in rate of infusion

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C0443172
If there was a change, please specify:
Descripción

Rate of infusion

Tipo de datos

integer

Unidades de medida
  • ml/hr
Alias
UMLS CUI [1]
C2964135
ml/hr
Blood pressure
Descripción

Blood pressure assessed

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C1516048
If assessed, please specify
Descripción

Systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
If assessed, please specify
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate assessed

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1516048
If assessed, please specify
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Treatment Confirmation
Descripción

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Descripción

Correct treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
If no, please record reason(s)
Descripción

Treatment wrong

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
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Similar models

Study Treatment

1 formularios
  1. StudyEvent: ODM
    1. Study Treatment
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
Cycle 1 week 1 (1)
CL Item
Cycle 1 week 2 (2)
CL Item
Cycle 1 week 3 (3)
CL Item
Cycle 1 week 4 (4)
CL Item
Cycle 2 week 1 (5)
CL Item
Cycle 2 week 2  (6)
CL Item
Cycle 2 week 3  (7)
CL Item
Cycle 2 week 4 (8)
Item Group
Pre-Medications
C0033045 (UMLS CUI-1)
Premedication, sequence number
Item
Sequence number
text
C0033045 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Drug name
Item
Drug name
text
C0033045 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Premedication, modified reported term
Item
Modified reported term
text
C0033045 (UMLS CUI [1,1])
C2826819 (UMLS CUI [1,2])
GSK drug synonym
Item
GSK drug synonym
text
C0033045 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK drug collection code
Item
GSK drug collection code
text
C0033045 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Premedication, Failed coding
Item
Failed coding
text
C0033045 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Premedication, Total daily dose
Item
Total daily dose
integer
C0033045 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0033045 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
intravenous (IV)
CL Item
oral (PO)
Premedication, Start date
Item
Start date
partialDate
C0033045 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Premedication ongoing
Item
Ongoing?
boolean
C0033045 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Premedication, end date
Item
If no, please specify end date.
partialDate
C0033045 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Ofatumumab Infusion Details
C1832027 (UMLS CUI-1)
C0574032 (UMLS CUI-2)
C0242482 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
Investigational Product Infusion
Item
Did the subject receive Investigatonal Product?
boolean
C0304229 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
Investigational Product, infusion start date and time
Item
If yes, please state start date and time
partialDatetime
C0304229 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C3897500 (UMLS CUI [1,3])
Investigational product, infusion end date and time
Item
If yes, please state end date and time
partialDatetime
C0304229 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C3899266 (UMLS CUI [1,3])
Actual dose of Ofatumumab
Item
If yes, please state actual dose of Ofatumumab
integer
C1832027 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Investigational Product, total volume infused
Item
If yes, please state total volume infused
integer
C0304229 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,3])
Item
If yes, was the infusion interrupted or stopped?
text
C0304229 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C0457454 (UMLS CUI [2,3])
Investigational product, infusion interrupted or stopped?
Code List
If yes, was the infusion interrupted or stopped?
CL Item
No (N)
CL Item
Yes, due to an AE (1)
CL Item
Yes, due to a reason other than AE (OT)
Item
If the subject did not receive the investigational product, please specify the reason.
integer
C0304229 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Investigational product, reason for not receiving
Code List
If the subject did not receive the investigational product, please specify the reason.
CL Item
subject refused (2)
CL Item
adverse event (3)
CL Item
other (4)
Investigational product, other reason for not receiving
Item
If other, please specify
text
C0304229 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Infusion Vitals Details Entry
C1832027 (UMLS CUI-1)
C0574032 (UMLS CUI-2)
C0518766 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
Start time of Infusion vitals
Item
Start time
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,3])
Item
Rate of infusion
text
C2964135 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Rate of infusion
Code List
Rate of infusion
CL Item
change (98)
CL Item
no change (1)
Rate of infusion
Item
If there was a change, please specify:
integer
C2964135 (UMLS CUI [1])
Item
Blood pressure
text
C0005823 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Blood pressure
Code List
Blood pressure
CL Item
assessed  (97)
CL Item
not assessed (2)
Systolic blood pressure
Item
If assessed, please specify
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
If assessed, please specify
integer
C0428883 (UMLS CUI [1])
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Heart rate
Code List
Heart rate
CL Item
assessed (96)
CL Item
not assessed (2)
Heart rate
Item
If assessed, please specify
integer
C0018810 (UMLS CUI [1])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Correct treatment
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Treatment wrong
Item
If no, please record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
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