ID
30233
Beschrijving
https://clinicaltrials.gov/show/NCT00989664 Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7 Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin
Link
https://clinicaltrials.gov/show/NCT00989664
Trefwoorden
Versies (1)
- 23-05-18 23-05-18 -
Houder van rechten
GlaxoSmithKline (GSK)
Geüploaded op
23 mei 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664
Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Time (24 hr)
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
BP (mmHg)
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Pulse (bpm)
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temp.
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
If yes, please record on AE page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Therapy Dose - Day 7
Alias
- UMLS CUI-1
- C3174092
- UMLS CUI-2
- C0304229
Beschrijving
Date administered
Datatype
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Beschrijving
Day 5 HAMA date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1291910
Beschrijving
HAMA Result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1291910
- UMLS CUI [1,2]
- C1274040
Beschrijving
Time started (24 hour clock)
Datatype
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1301880
Beschrijving
Time started (24 hour clock)
Datatype
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1301880
Beschrijving
Time started (24 hour clock)
Datatype
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1301880
Beschrijving
Time started (24 hour clock)
Datatype
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1301880
Beschrijving
Time finished (24 hour clock)
Datatype
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1522314
Beschrijving
Time finished (24 hour clock)
Datatype
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1522314
Beschrijving
Time finished (24 hour clock)
Datatype
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1522314
Beschrijving
Time finished (24 hour clock)
Datatype
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1522314
Beschrijving
Anti-B1 dose (cold dose)
Datatype
integer
Maateenheden
- mg
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C3174092
Beschrijving
Lot number of Anti-B1
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C0768182
Beschrijving
Anti-B1 dose (hot dose)
Datatype
integer
Maateenheden
- mg
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C3174092
Beschrijving
Lot number of Anti-B1
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C0768182
Beschrijving
lodine-131 Anti-B1 (prescribed)
Datatype
integer
Maateenheden
- mCi
Alias
- UMLS CUI [1]
- C0768182
Beschrijving
Lot number (Nordion)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C3854006
Beschrijving
Whole body dose (prescribed)
Datatype
integer
Maateenheden
- cGy
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0278329
- UMLS CUI [1,3]
- C0444584
Beschrijving
Dose attenuation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1707811
- UMLS CUI [1,2]
- C0028754
Beschrijving
Infusion rate adjustment
Datatype
boolean
Alias
- UMLS CUI [1]
- C2964135
Beschrijving
Infusion rate adjustment
Datatype
integer
Alias
- UMLS CUI [1]
- C2964135
Beschrijving
Reason for adjustment
Datatype
integer
Alias
- UMLS CUI [1]
- C2826286
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Time (24 hr)
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
BP (mmHg)
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Pulse (bpm)
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temp.
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
If yes, please record on AE page.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Protocol compliance of patient
Datatype
boolean
Alias
- UMLS CUI [1]
- C0525058
Beschrijving
Protocol compliance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C1299582
Similar models
Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7
C0304229 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1291910 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,2])
C0768182 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C0768182 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1291910 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,2])
C0768182 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C0768182 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,2])
C0444584 (UMLS CUI [1,3])
C0028754 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])