ID

42068

Beskrivning

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Nyckelord

Versioner (4)
  1. 2018-07-08 2018-07-08 -
  2. 2018-07-21 2018-07-21 -
  3. 2018-08-18 2018-08-18 -
  4. 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 mars 2021

DOI

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Licens

Creative Commons BY-NC 3.0
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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

Engelsk

Prior Therapy

1 Formulär  
  1. StudyEvent: ODM
    1. Prior Therapy
Prior Therapy
Beskrivning

Prior Therapy

Alias
UMLS CUI-1
C1514463
Series page
Beskrivning

undefined item

Datatyp

text

Alias
UMLS CUI [1,1]
C0205549
UMLS CUI [1,2]
C1704732
Last page
Beskrivning

Last page

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1517741
Drugs
Beskrivning

Drugs

Alias
UMLS CUI-1
C0013227
Chemotherapy Code
Beskrivning

Chemotherapy Code

Datatyp

text

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0805701
Drugs
Beskrivning

List drug names only if code is not given

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Therapy Start Date (mm/dd/yy)
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C3173309
Therapy Stop Date (mm/dd/yy)
Beskrivning

End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0806020
Number of Cycles
Beskrivning

Chemotherapy cycle; Count of entities

Datatyp

integer

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C0237753
Therapy Outcome
Beskrivning

Outcome of Therapy

Datatyp

text

Alias
UMLS CUI [1]
C1518681
Duration of Response (months)
Beskrivning

Response Duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1]
C0237585
months
Prior Radiation Therapy
Beskrivning

Prior Radiation Therapy

Alias
UMLS CUI-1
C1522449
UMLS CUI-2
C0332152
Therapy Start Date (mm/dd/yy)
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C3173309
Therapy Stop Date (mm/dd/yy)
Beskrivning

End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0806020
Total Dose in cGY
Beskrivning

radiation therapy pattern total dose (___cGy)

Datatyp

float

Måttenheter
  • cGy
Alias
UMLS CUI [1]
C2169193
cGy
Location (sites treated)
Beskrivning

Location; Therapeutic procedure

Datatyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0450429
Therapy Outcome at Irradiated Location
Beskrivning

irradiation site; Outcome of Therapy

Datatyp

text

Alias
UMLS CUI [1,1]
C2169202
UMLS CUI [1,2]
C1518681
Duration of Response (months)
Beskrivning

Duration of Response

Datatyp

text

Alias
UMLS CUI [1]
C0237585
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Similar models

Prior Therapy

1 Formulär
  1. StudyEvent: ODM
    1. Prior Therapy
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Prior Therapy
C1514463 (UMLS CUI-1)
undefined item
Item
Series page
text
C0205549 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Last page
Item
Last page
boolean
C1704732 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Item Group
Drugs
C0013227 (UMLS CUI-1)
Item
Chemotherapy Code
text
C3665472 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Chemotherapy Code
Code List
Chemotherapy Code
CL Item
CVP (1)
CL Item
C-MOPP (2)
CL Item
BACOP (3)
CL Item
COP- Bleo (4)
CL Item
CHOP (5)
CL Item
CHOP- Bleo (6)
CL Item
CP (7)
CL Item
Cytoxan (8)
CL Item
COPP (9)
CL Item
Pro- MACE- MOPP (10)
CL Item
CHOP- Bleo + Alpha Interferon (11)
CL Item
COMLA (12)
CL Item
Fludarabine (13)
CL Item
ACP (14)
CL Item
MINE (15)
CL Item
ESHAP (16)
CL Item
DHAP (17)
CL Item
EPOCH (18)
CL Item
CEPP (19)
CL Item
Pro- MACE- CytaBOM (20)
CL Item
ICE (21)
CL Item
COP- BLAM (22)
CL Item
CNOP (23)
CL Item
FND (24)
CL Item
MACOP- B (25)
CL Item
m- BACOD (26)
CL Item
VAPEC- B (27)
CL Item
IM- VP 16 (28)
CL Item
CF (29)
CL Item
Other (specify) (30)
CL Item
Chlorambucil (49)
CL Item
Rituximab (64)
Pharmaceutical Preparations
Item
Drugs
text
C0013227 (UMLS CUI [1])
Start Date
Item
Therapy Start Date (mm/dd/yy)
date
C3173309 (UMLS CUI [1])
End Date
Item
Therapy Stop Date (mm/dd/yy)
date
C0087111 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Chemotherapy cycle; Count of entities
Item
Number of Cycles
integer
C1302181 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Therapy Outcome
text
C1518681 (UMLS CUI [1])
Outcome of Therapy
Code List
Therapy Outcome
CL Item
PD (1)
(Comment:en)
CL Item
SD (2)
(Comment:en)
CL Item
PR (3)
(Comment:en)
CL Item
CCR (4)
(Comment:en)
CL Item
CR (5)
(Comment:en)
CL Item
Unknown (0)
(Comment:en)
Response Duration
Item
Duration of Response (months)
integer
C0237585 (UMLS CUI [1])
Item Group
Prior Radiation Therapy
C1522449 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
Start Date
Item
Therapy Start Date (mm/dd/yy)
date
C3173309 (UMLS CUI [1])
End Date
Item
Therapy Stop Date (mm/dd/yy)
date
C0087111 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
radiation therapy pattern total dose (___cGy)
Item
Total Dose in cGY
float
C2169193 (UMLS CUI [1])
Location; Therapeutic procedure
Item
Location (sites treated)
text
C0087111 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Item
Therapy Outcome at Irradiated Location
text
C2169202 (UMLS CUI [1,1])
C1518681 (UMLS CUI [1,2])
irradiation site; Outcome of Therapy
Code List
Therapy Outcome at Irradiated Location
CL Item
PD (1)
CL Item
SD (2)
CL Item
PR (3)
CL Item
CCR (4)
CL Item
CR (5)
CL Item
Unknown (0)
Duration of Response
Item
Duration of Response (months)
text
C0237585 (UMLS CUI [1])
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