ID

30233

Beschreibung

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

Stichworte

Versionen (1)
  1. 23.05.18 23.05.18 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

23. Mai 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

Englisch

Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7

1 Formulare  
Dosimetric Dose - Day 0
Beschreibung

Dosimetric Dose - Day 0

Alias
UMLS CUI-1
C3174092
UMLS CUI-2
C0304229
Date administered
Beschreibung

Date administered

Datentyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Baseline HAMA date
Beschreibung

Baseline HAMA date

Datentyp

date

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0011008
HAMA Result
Beschreibung

HAMA Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C1291910
UMLS CUI [1,3]
C1274040
Time started (24 hour clock): (cold)
Beschreibung

Time started (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1301880
Time started (24 hour clock): (cold flush)
Beschreibung

Time started (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1301880
Time started (24 hour clock): (hot)
Beschreibung

Time started (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1301880
Time started (24 hour clock): (hot flush)
Beschreibung

Time started (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1301880
Time finished (24 hour clock): (cold)
Beschreibung

Time finished (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1522314
Time finished (24 hour clock): (cold)
Beschreibung

Time finished (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1522314
Time finished (24 hour clock): (hot)
Beschreibung

Time finished (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1522314
Time finished (24 hour clock): (hot flush)
Beschreibung

Time finished (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1522314
Anti-B1 dose (cold dose)
Beschreibung

Anti-B1 dose (cold dose)

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C3174092
mg
Lot number of Anti-B1
Beschreibung

Lot number of Anti-B1

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C0768182
Anti-B1 dose (hot dose)
Beschreibung

Anti-B1 dose (hot dose)

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C3174092
mg
Lot number of Anti-B1
Beschreibung

Lot number of Anti-B1

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C0768182
lodine-131 Anti-B1 (prescribed)
Beschreibung

lodine-131 Anti-B1 (prescribed)

Datentyp

integer

Maßeinheiten
  • mCi
Alias
UMLS CUI [1]
C0768182
mCi
Lot number (Nordion)
Beschreibung

Lot number (Nordion)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C3854006
Did infusion rate need to be adjusted?
Beschreibung

Infusion rate adjustment

Datentyp

boolean

Alias
UMLS CUI [1]
C2964135
If yes, was infusion rate
Beschreibung

Infusion rate adjustment

Datentyp

integer

Alias
UMLS CUI [1]
C2964135
If infusion rate was adjusted, was it for:
Beschreibung

Reason for adjustment

Datentyp

integer

Alias
UMLS CUI [1]
C2826286
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Time (24 hr)
Beschreibung

Time (24 hr)

Datentyp

time

Alias
UMLS CUI [1]
C0040223
BP (mmHg)
Beschreibung

BP (mmHg)

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse (bpm)
Beschreibung

Pulse (bpm)

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temp.
Beschreibung

Temp.

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Did the patient have any adverse experiences?
Beschreibung

If yes, please record on AE page.

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Therapy Dose - Day 7
Beschreibung

Therapy Dose - Day 7

Alias
UMLS CUI-1
C3174092
UMLS CUI-2
C0304229
Date administered
Beschreibung

Date administered

Datentyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Day 5 HAMA date
Beschreibung

Day 5 HAMA date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1291910
Result
Beschreibung

HAMA Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1274040
Time started (24 hour clock): (cold)
Beschreibung

Time started (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1301880
Time started (24 hour clock): (cold flush)
Beschreibung

Time started (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1301880
Time started (24 hour clock): (hot)
Beschreibung

Time started (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1301880
Time started (24 hour clock): (hot flush)
Beschreibung

Time started (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1301880
Time finished (24 hour clock): (cold)
Beschreibung

Time finished (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1522314
Time finished (24 hour clock): (cold flush)
Beschreibung

Time finished (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1522314
Time finished (24 hour clock): (hot)
Beschreibung

Time finished (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1522314
Time finished (24 hour clock): (hot flush)
Beschreibung

Time finished (24 hour clock)

Datentyp

time

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1522314
Anti-B1 dose (cold dose)
Beschreibung

Anti-B1 dose (cold dose)

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C3174092
mg
Lot number of Anti-B1
Beschreibung

Lot number of Anti-B1

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C0768182
Anti-B1 dose (hot dose)
Beschreibung

Anti-B1 dose (hot dose)

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C3174092
mg
Lot number of Anti-B1
Beschreibung

Lot number of Anti-B1

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C0768182
lodine-131 Anti-B1 (prescribed)
Beschreibung

lodine-131 Anti-B1 (prescribed)

Datentyp

integer

Maßeinheiten
  • mCi
Alias
UMLS CUI [1]
C0768182
mCi
Lot number (Nordion)
Beschreibung

Lot number (Nordion)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1115660
UMLS CUI [1,2]
C3854006
Whole body dose (prescribed)
Beschreibung

Whole body dose (prescribed)

Datentyp

integer

Maßeinheiten
  • cGy
Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0278329
UMLS CUI [1,3]
C0444584
cGy
Was dose attenuated for obesity?
Beschreibung

Dose attenuation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707811
UMLS CUI [1,2]
C0028754
Did infusion rate need to be adjusted?
Beschreibung

Infusion rate adjustment

Datentyp

boolean

Alias
UMLS CUI [1]
C2964135
If yes, was infusion rate
Beschreibung

Infusion rate adjustment

Datentyp

integer

Alias
UMLS CUI [1]
C2964135
If infusion rate was adjusted, was it for:
Beschreibung

Reason for adjustment

Datentyp

integer

Alias
UMLS CUI [1]
C2826286
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Time (24 hr)
Beschreibung

Time (24 hr)

Datentyp

time

Alias
UMLS CUI [1]
C0040223
BP (mmHg)
Beschreibung

BP (mmHg)

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse (bpm)
Beschreibung

Pulse (bpm)

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temp.
Beschreibung

Temp.

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Did the patient have any adverse experiences?
Beschreibung

If yes, please record on AE page.

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Was patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?
Beschreibung

Protocol compliance of patient

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
If No, please explain:
Beschreibung

Protocol compliance

Datentyp

text

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C1299582
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Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Dosimetric Dose - Day 0
C3174092 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Date administered
Item
Date administered
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Baseline HAMA date
Item
Baseline HAMA date
date
C1291910 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
HAMA Result
integer
C1442488 (UMLS CUI [1,1])
C1291910 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
HAMA Result
Code List
HAMA Result
CL Item
Positive (1)
CL Item
Negative (2)
Time started (24 hour clock)
Item
Time started (24 hour clock): (cold)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Time started (24 hour clock)
Item
Time started (24 hour clock): (cold flush)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Time started (24 hour clock)
Item
Time started (24 hour clock): (hot)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Time started (24 hour clock)
Item
Time started (24 hour clock): (hot flush)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Time finished (24 hour clock)
Item
Time finished (24 hour clock): (cold)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Time finished (24 hour clock)
Item
Time finished (24 hour clock): (cold)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Time finished (24 hour clock)
Item
Time finished (24 hour clock): (hot)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Time finished (24 hour clock)
Item
Time finished (24 hour clock): (hot flush)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Anti-B1 dose (cold dose)
Item
Anti-B1 dose (cold dose)
integer
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Lot number of Anti-B1
Item
Lot number of Anti-B1
integer
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
Anti-B1 dose (hot dose)
Item
Anti-B1 dose (hot dose)
integer
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Lot number of Anti-B1
Item
Lot number of Anti-B1
integer
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
lodine-131 Anti-B1 (prescribed)
Item
lodine-131 Anti-B1 (prescribed)
integer
C0768182 (UMLS CUI [1])
Lot number (Nordion)
Item
Lot number (Nordion)
integer
C1115660 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Infusion rate adjustment
Item
Did infusion rate need to be adjusted?
boolean
C2964135 (UMLS CUI [1])
Item
If yes, was infusion rate
integer
C2964135 (UMLS CUI [1])
Infusion rate adjustment
Code List
If yes, was infusion rate
CL Item
decreased by 1/2 (1)
CL Item
discontinued (2)
CL Item
other (3)
Item
If infusion rate was adjusted, was it for:
integer
C2826286 (UMLS CUI [1])
Reason for adjustment
Code List
If infusion rate was adjusted, was it for:
CL Item
↓ SBP (1)
CL Item
rigors (2)
CL Item
fever (3)
CL Item
mucosal congestion/edema (4)
CL Item
other (5)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Time (24 hr)
Item
Time (24 hr)
time
C0040223 (UMLS CUI [1])
BP (mmHg)
Item
BP (mmHg)
integer
C0005823 (UMLS CUI [1])
Pulse (bpm)
Item
Pulse (bpm)
integer
C0232117 (UMLS CUI [1])
Temp.
Item
Temp.
float
C0005903 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Adverse Events
Item
Did the patient have any adverse experiences?
boolean
C0877248 (UMLS CUI [1])
Item Group
Therapy Dose - Day 7
C3174092 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Date administered
Item
Date administered
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Day 5 HAMA date
Item
Day 5 HAMA date
date
C0011008 (UMLS CUI [1,1])
C1291910 (UMLS CUI [1,2])
Item
Result
integer
C1291910 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
HAMA Result
Code List
Result
CL Item
Positive (1)
CL Item
Negative (2)
Time started (24 hour clock)
Item
Time started (24 hour clock): (cold)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Time started (24 hour clock)
Item
Time started (24 hour clock): (cold flush)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Time started (24 hour clock)
Item
Time started (24 hour clock): (hot)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Time started (24 hour clock)
Item
Time started (24 hour clock): (hot flush)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Time finished (24 hour clock)
Item
Time finished (24 hour clock): (cold)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Time finished (24 hour clock)
Item
Time finished (24 hour clock): (cold flush)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Time finished (24 hour clock)
Item
Time finished (24 hour clock): (hot)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Time finished (24 hour clock)
Item
Time finished (24 hour clock): (hot flush)
time
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Anti-B1 dose (cold dose)
Item
Anti-B1 dose (cold dose)
integer
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Lot number of Anti-B1
Item
Lot number of Anti-B1
integer
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
Anti-B1 dose (hot dose)
Item
Anti-B1 dose (hot dose)
integer
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Lot number of Anti-B1
Item
Lot number of Anti-B1
integer
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
lodine-131 Anti-B1 (prescribed)
Item
lodine-131 Anti-B1 (prescribed)
integer
C0768182 (UMLS CUI [1])
Lot number (Nordion)
Item
Lot number (Nordion)
integer
C1115660 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Whole body dose (prescribed)
Item
Whole body dose (prescribed)
integer
C0678766 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0444584 (UMLS CUI [1,3])
Dose attenuation
Item
Was dose attenuated for obesity?
boolean
C1707811 (UMLS CUI [1,1])
C0028754 (UMLS CUI [1,2])
Infusion rate adjustment
Item
Did infusion rate need to be adjusted?
boolean
C2964135 (UMLS CUI [1])
Item
If yes, was infusion rate
integer
C2964135 (UMLS CUI [1])
Infusion rate adjustment
Code List
If yes, was infusion rate
CL Item
decreased by 1/2  (1)
CL Item
discontinued  (2)
CL Item
other (3)
Item
If infusion rate was adjusted, was it for:
integer
C2826286 (UMLS CUI [1])
Reason for adjustment
Code List
If infusion rate was adjusted, was it for:
CL Item
SBP  (1)
CL Item
rigors  (2)
CL Item
fever  (3)
CL Item
mucosal congestion/edema  (4)
CL Item
other (5)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Time (24 hr)
Item
Time (24 hr)
time
C0040223 (UMLS CUI [1])
BP (mmHg)
Item
BP (mmHg)
integer
C0005823 (UMLS CUI [1])
Pulse (bpm)
Item
Pulse (bpm)
integer
C0232117 (UMLS CUI [1])
Temp.
Item
Temp.
float
C0005903 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Adverse Events
Item
Did the patient have any adverse experiences?
boolean
C0877248 (UMLS CUI [1])
Protocol compliance of patient
Item
Was patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?
boolean
C0525058 (UMLS CUI [1])
Protocol compliance
Item
If No, please explain:
text
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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