ID

42547

Beschrijving

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 whenever/if blood products, blood supportive care products or other concomitant medication is administered during study.

Link

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

Trefwoorden

Versies (1)
  1. 25-08-21 25-08-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 augustus 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Engels

Blood products, blood supportive care and concomitant medication

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

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

date of visit/assessment

Datatype

date

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

subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Blood Products and Blood Supportive Care Products
Beschrijving

Blood Products and Blood Supportive Care Products

Alias
UMLS CUI-1
C0456388
UMLS CUI-2
C0018938
Sequence Number
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C2348184
UMLS CUI [2,1]
C0018938
UMLS CUI [2,2]
C2348184
Blood Products and Blood Supportive Care Products
Beschrijving

Blood Products and Blood Supportive Care Products

Datatype

text

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2]
C0018938
Other Blood Product, specify
Beschrijving

Other Blood Products, specification

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0456388
UMLS CUI [1,3]
C1521902
Other Blood Supportive Care Product, specify
Beschrijving

Other Blood Supportive Care Products, specification

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0018938
UMLS CUI [1,3]
C1521902
Cumulative Quantity or Dose
Beschrijving

Blood Products and Blood Supportive Care Products, Cumulative Dose

Datatype

text

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C2986497
UMLS CUI [2,1]
C0018938
UMLS CUI [2,2]
C2986497
Units
Beschrijving

Blood Products and Blood Supportive Care Products, Units

Datatype

text

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C1519795
UMLS CUI [2,1]
C0018938
UMLS CUI [2,2]
C1519795
Start Date
Beschrijving

Blood Products and Blood Supportive Care Products, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0018938
UMLS CUI [2,2]
C0808070
Stop Date
Beschrijving

Blood Products and Blood Supportive Care Products, Stop Date

Datatype

date

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0018938
UMLS CUI [2,2]
C0806020
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Sequence Number
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Drug Name
Beschrijving

(Trade Name preferred)

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Modified reported term
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0871468
UMLS CUI [1,4]
C2347796
GSK Drug Collection code
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1516698
UMLS CUI [1,4]
C0805701
UMLS CUI [1,5]
C2347796
Failed coding
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0231175
Total Daily Dose
Beschrijving

Concomitant Medications, Total Daily Dose

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Units
Beschrijving

Concomitant Medications, Units

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
Route
Beschrijving

Concomitant Medications, Route

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Reason for Medication
Beschrijving

Concomitant medications, Reason for Medication

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Taken Prior to Study?
Beschrijving

Concomitant Medication, Taken prior to Study

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C1883727
UMLS CUI [1,4]
C0332152
Start Date
Beschrijving

Concomitant Medication, Start Date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Ongoing?
Beschrijving

Concomitant Medication, ongoing

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
If no, specify End Date
Beschrijving

Concomitant Medication, not ongoing

Datatype

date

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C1521902
Terug naar het begin van de pagina

Similar models

Blood products, blood supportive care and concomitant medication

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 Group
Blood Products and Blood Supportive Care Products
C0456388 (UMLS CUI-1)
C0018938 (UMLS CUI-2)
Blood products and blood productive care products, Sequence Number
Item
Sequence Number
text
C0456388 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C0018938 (UMLS CUI [2,1])
C2348184 (UMLS CUI [2,2])
Item
Blood Products and Blood Supportive Care Products
text
C0456388 (UMLS CUI [1])
C0018938 (UMLS CUI [2])
Blood Products and Blood Supportive Care Products
Code List
Blood Products and Blood Supportive Care Products
CL Item
Red Blood Cells (RBC)
CL Item
Platelets (PLTS)
CL Item
Whole Blood (WB)
CL Item
Plasma - FFP (FFP)
CL Item
Factor VIII (FVIII)
CL Item
Cryoprecipitate (CRYOP)
CL Item
White Blood Cells (WBC)
CL Item
Other Blood Product (OTBP)
CL Item
G-CSF (GCSF)
CL Item
Prophylactic G-CSF (GCSFP)
CL Item
Treatment G-SCF (GCSFT)
CL Item
G(M)CSF (GMCSF)
CL Item
Erythropoietin (EPO)
CL Item
Pegfilgrastim (Conjugated G-CSF/Neulasta) (PGSF)
CL Item
Oprelvecin (IL-11) (IL11)
CL Item
Granocyte (Lenograstim) (GRANO)
CL Item
Neupogen (Filgrastim) - r-metHuG-CSF (NEUPO)
CL Item
Other Blood Supportive Care Product (OTBSC)
Other Blood Products, specification
Item
Other Blood Product, specify
text
C0205394 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other Blood Supportive Care Products, specification
Item
Other Blood Supportive Care Product, specify
text
C0205394 (UMLS CUI [1,1])
C0018938 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Blood Products and Blood Supportive Care Products, Cumulative Dose
Item
Cumulative Quantity or Dose
text
C0456388 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0018938 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
Item
Units
text
C0456388 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0018938 (UMLS CUI [2,1])
C1519795 (UMLS CUI [2,2])
Blood Products and Blood Supportive Care Products, Units
Code List
Units
CL Item
Actuation  (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (APP)
CL Item
Area under curve (AUC)
CL Item
Bottle (BOT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter  (CC)
CL Item
Cup (CUP)
CL Item
Finger Tip Unit  (FTU)
CL Item
Gamma per kilogram per minute (GA/KG/MIN)
CL Item
Gram  (G)
CL Item
Grams per kilogram (G/KG)
CL Item
Grams per litre (G/L)
CL Item
Grams per metre squared (G/M2)
CL Item
Grams per millilitre (G/ML)
CL Item
Drops (GTT)
CL Item
100 International Units/ml (100IU/ML)
CL Item
Inhalation (INH)
CL Item
International units  (IU)
CL Item
International units per kilogram  (IU/KG)
CL Item
International units per kilogram per hour (IU/KG/HR)
CL Item
International units per millilitre  (IU/ML)
CL Item
Litre  (L)
CL Item
Lozenge  (LOZ)
CL Item
Litre per minute  (L/MIN)
CL Item
Lozenge  (LOZ)
CL Item
Minimum alveolar concentration  (MAC)
CL Item
Mega becquerels (MBq) (MBQ)
CL Item
Microgram (MCG)  (MCG)
CL Item
Micrograms per gram (MCG/G)
CL Item
Micrograms per hour (MCG/HR)
CL Item
Microgram per kilogram  (MCG/KG)
CL Item
Microgram/kilogram per minute  (MCG/KG/MIN)
CL Item
Micrograms per minute  (MCG/MIN)
CL Item
Micrograms per millilitre (MCG/ML)
CL Item
Millicurie (MCI)
CL Item
Microlitre  (MCL)
CL Item
Milliequivalent  (MEQ)
CL Item
Milliequivalent per 24 hours  (MEQ/24HR)
CL Item
Milligram  (MG)
CL Item
Milligram per day (MG/DAY)
CL Item
Milligram per hour  (MG/HR)
CL Item
Milligram/kilogram  (MG/KG)
CL Item
Milligram/kilogram per hour (MG/KG/HR)
CL Item
Milligram/kilogram per minute  (MG/KG/MIN)
CL Item
Milligram/metre squared  (MG/M2)
CL Item
Milligram/millilitre  (MG/ML)
CL Item
Milligrams percent (MG%)
CL Item
Million international units (MIU)
CL Item
Millilitre  (ML)
CL Item
Millilitre per hour  (ML/HR)
CL Item
Millilitre per minute  (ML/MIN)
CL Item
Millimole  (MMOL)
CL Item
Millimole per kilogram (MMOL/KG)
CL Item
Megaunits (million units)  (MU)
CL Item
Nebule (NEB)
CL Item
Ounce (OZ)
CL Item
Pack (PACK)
CL Item
Patch (PATCH)
CL Item
Percent (%)
CL Item
Puff (PUFF)
CL Item
Sachet  (SACH)
CL Item
Spray  (SPR)
CL Item
Suppository  (SUPP)
CL Item
Tablet  (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon  (TSP)
CL Item
Microgram (UG) (UG)
CL Item
Units per hour (U/HR)
CL Item
Units per kilogram per minute  (U/KG/MIN)
CL Item
Units per minute (U/MIN)
CL Item
Micromoles per 24 hours (UMOL/24HR)
CL Item
Units (U)
CL Item
Unknown (UNK)
CL Item
Units per gram (U/G)
CL Item
Vial  (VIAL)
Blood Products and Blood Supportive Care Products, Start Date
Item
Start Date
date
C0456388 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0018938 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
Blood Products and Blood Supportive Care Products, Stop Date
Item
Stop Date
date
C0456388 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0018938 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medications, Sequence Number
Item
Sequence Number
text
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Medications, Drug Name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medications, Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Medications, GSK Drug synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
C2347796 (UMLS CUI [1,4])
Concomitant Medications, GSK Drug Collection code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])
Concomitant Medications, Failed coding
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Concomitant Medications, Total Daily Dose
Item
Total Daily Dose
text
C2347852 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Item
Units
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Concomitant Medications, Units
Code List
Units
CL Item
Actuation  (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (APP)
CL Item
Area under curve (AUC)
CL Item
Bottle (BOT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter  (CC)
CL Item
Cup (CUP)
CL Item
Finger Tip Unit  (FTU)
CL Item
Gamma per kilogram per minute (GA/KG/MIN)
CL Item
Gram  (G)
CL Item
Grams per kilogram (G/KG)
CL Item
Grams per litre (G/L)
CL Item
Grams per metre squared (G/M2)
CL Item
Grams per millilitre (G/ML)
CL Item
Drops (GTT)
CL Item
100 International Units/ml (100IU/ML)
CL Item
Inhalation (INH)
CL Item
International units  (IU)
CL Item
International units per kilogram  (IU/KG)
CL Item
International units per kilogram per hour (IU/KG/HR)
CL Item
International units per millilitre  (IU/ML)
CL Item
Litre  (L)
CL Item
Lozenge (LOZ)
CL Item
Litre per minute  (L/MIN)
CL Item
Lozenge  (LOZ)
CL Item
Minimum alveolar concentration  (MAC)
CL Item
Mega becquerels (MBq) (MBQ)
CL Item
Microgram (MCG)  (MCG)
CL Item
Micrograms per gram (MCG/G)
CL Item
Micrograms per hour (MCG/HR)
CL Item
Microgram per kilogram  (MCG/KG)
CL Item
Microgram/kilogram per minute  (MCG/KG/MIN)
CL Item
Micrograms per minute  (MCG/MIN)
CL Item
Micrograms per millilitre (MCG/ML)
CL Item
Millicurie (MCI)
CL Item
Microlitre  (MCL)
CL Item
Milliequivalent  (MEQ)
CL Item
Milliequivalent per 24 hours  (MEQ/24HR)
CL Item
Milligram  (MG)
CL Item
Milligram per day (MG/DAY)
CL Item
Milligram per hour  (MG/HR)
CL Item
Milligram/kilogram  (MG/KG)
CL Item
Milligram/kilogram per hour (MG/KG/HR)
CL Item
Milligram/kilogram per minute  (MG/KG/MIN)
CL Item
Milligram/metre squared  (MG/M2)
CL Item
Milligram/millilitre  (MG/ML)
CL Item
Milligrams percent (MG%)
CL Item
Million international units (MIU)
CL Item
Millilitre  (ML)
CL Item
Millilitre per hour  (ML/HR)
CL Item
Millilitre per minute  (ML/MIN)
CL Item
Millimole  (MMOL)
CL Item
Millimole per kilogram (MMOL/KG)
CL Item
Megaunits (million units)  (MU)
CL Item
Nebule (NEB)
CL Item
Ounce (OZ)
CL Item
Pack (PACK)
CL Item
Patch (PATCH)
CL Item
Percent (%)
CL Item
Puff (PUFF)
CL Item
Sachet  (SACH)
CL Item
Spray  (SPR)
CL Item
Suppository  (SUPP)
CL Item
Tablet  (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon  (TSP)
CL Item
Microgram (UG) (UG)
CL Item
Units per hour (U/HR)
CL Item
Units per kilogram per minute  (U/KG/MIN)
CL Item
Units per minute (U/MIN)
CL Item
Micromoles per 24 hours (UMOL/24HR)
CL Item
Units (U)
CL Item
Unknown (UNK)
CL Item
Units per gram (U/G)
CL Item
Vial (VIAL)
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Medications, Units
Code List
Route
CL Item
Gastrostomy tube  (GTT)
CL Item
Intrauterine (IU)
CL Item
Unknown (UNK)
CL Item
Epidural  (EP)
CL Item
Intra-arterial  (IA)
CL Item
Intra-articular  (IART)
CL Item
Intra-bursa  (IB)
CL Item
Intradermal (ID)
CL Item
Inhalation  (IH)
CL Item
Intralesional (ILES)
CL Item
Intramuscular (IM)
CL Item
Intranasal (IN)
CL Item
Injection  (INJ)
CL Item
Intraocular  (IO)
CL Item
Intraosteal  (IOS)
CL Item
Intraperitoneal (IP)
CL Item
Intrathecal  (IT)
CL Item
Intravenous  (IV)
CL Item
Jejunostomy feeding tube (JEJ or PEJ)  (JEJ)
CL Item
Nasogastric  (NG)
CL Item
Nasal (NS)
CL Item
Right eye  (OD)
CL Item
Ophthalmic (OP)
CL Item
Left eye  (OS)
CL Item
Otic  (OT)
CL Item
Other  (OTH)
CL Item
Both eyes  (OU)
CL Item
Oral  (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Transmucosal (TM)
CL Item
Topical  (TP)
CL Item
Vaginal  (VG)
Concomitant medications, Reason for Medication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Concomitant Medication, Taken prior to Study
Item
Taken Prior to Study?
boolean
C2347852 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Concomitant Medication, Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medication, ongoing
Item
Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication, not ongoing
Item
If no, specify End Date
date
C2826666 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial