ID
42082
Beschrijving
Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin
Trefwoorden
Versies (2)
- 29-03-21 29-03-21 -
- 29-03-21 29-03-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
29 maart 2021
DOI
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Licentie
Creative Commons BY 4.0
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Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758
Infection Summary; Concomitant Medications and Transfusions; Adverse Experiences
Beschrijving
Infection Summary
Alias
- UMLS CUI-1
- C0009450
- UMLS CUI-2
- C1706244
Beschrijving
If No, do not complete remainder of form. If Yes, complete remainder of form.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205281
- UMLS CUI [2]
- C0243026
- UMLS CUI [3]
- C0032285
- UMLS CUI [4,1]
- C2603343
- UMLS CUI [4,2]
- C0679823
Beschrijving
If no invasive infection, record date of visit
Datatype
date
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205281
- UMLS CUI [2]
- C1320303
Beschrijving
If invasive infection, enter date of infection
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205281
- UMLS CUI [2]
- C0011008
Beschrijving
Type of Infection
Datatype
integer
Alias
- UMLS CUI [1]
- C0457463
Beschrijving
Specify other type of infection
Datatype
text
Alias
- UMLS CUI [1,1]
- C0457463
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Method of confirmation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0025663
Beschrijving
Specify other method of confirmation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0025663
- UMLS CUI [2]
- C2348235
- UMLS CUI [3]
- C0205394
Beschrijving
If Yes, complete remaining culture information
Datatype
boolean
Alias
- UMLS CUI [1]
- C0430400
Beschrijving
Infection Summary - Culture information
Alias
- UMLS CUI-1
- C0009450
- UMLS CUI-2
- C1706244
- UMLS CUI-3
- C0430400
- UMLS CUI-4
- C1533716
Beschrijving
Source Code
Datatype
integer
Alias
- UMLS CUI [1]
- C1710131
Beschrijving
Specify other source code
Datatype
text
Alias
- UMLS CUI [1]
- C1710131
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
Culture Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C0011008
Beschrijving
Culture Result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
Beschrijving
If positive result, indicate organism code
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C1446409
- UMLS CUI [2,1]
- C0029235
- UMLS CUI [2,2]
- C0805701
Beschrijving
Specify other organism
Datatype
text
Alias
- UMLS CUI [1]
- C0029235
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
Infection Summary - Anti-infective
Alias
- UMLS CUI-1
- C0009450
- UMLS CUI-2
- C1706244
- UMLS CUI-3
- C0003204
Beschrijving
Infection Summary - Anti-infective
Alias
- UMLS CUI-1
- C0009450
- UMLS CUI-2
- C1706244
- UMLS CUI-3
- C0003204
Beschrijving
Anti-Infective
Datatype
text
Alias
- UMLS CUI [1]
- C0003204
Beschrijving
IV or PO
Datatype
integer
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Empiric or therapeutic?
Datatype
integer
Alias
- UMLS CUI [1]
- C1880496
- UMLS CUI [2]
- C0302350
Beschrijving
Anti-infective therapy start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1141958
- UMLS CUI [1,2]
- C0808070
Beschrijving
Anti-infective therapy stop date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1141958
- UMLS CUI [1,2]
- C0806020
Beschrijving
Anti-infective therapy ongoing?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1141958
- UMLS CUI [1,2]
- C0549178
Beschrijving
Concomitant Medications and Transfusions
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1879316
Beschrijving
Drug or Blood Product
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2]
- C0456388
Beschrijving
Medication Dose
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Medication Unit
Datatype
text
Alias
- UMLS CUI [1]
- C2826646
Beschrijving
Medication Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Medication Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Medication Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Medication Continuing?
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Adverse Experience Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0237753
Beschrijving
Adverse Experience
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Adverse Experience Grade
Datatype
text
Alias
- UMLS CUI [1]
- C2985911
Beschrijving
SERIOUS: Fatal or immediately life-threatening, permanently disabling, requires or prolongs hospitalization, congenital anomaly,cancer,or overdose
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Adverse Experience Onset Date
Datatype
date
Alias
- UMLS CUI [1]
- C2985916
Beschrijving
Adverse Experience Stop Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0806020
Beschrijving
Adverse Experience Ongoing
Datatype
text
Alias
- UMLS CUI [1]
- C2826663
Beschrijving
Therapeutic Measures - Drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0013227
Beschrijving
Record all that apply
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0079809
- UMLS CUI [1,3]
- C0205394
Beschrijving
Specify other therapeutic measure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0079809
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C2348235
Beschrijving
Adverse Experience Outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Adverse Experience Relationship to Drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0439849
Beschrijving
Adverse Experiences - Investigator Signature
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2346576
Similar models
Infection Summary; Concomitant Medications and Transfusions; Adverse Experiences
C0237753 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
C1704732 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2])
C0032285 (UMLS CUI [3])
C2603343 (UMLS CUI [4,1])
C0679823 (UMLS CUI [4,2])
C0205281 (UMLS CUI [1,2])
C1320303 (UMLS CUI [2])
C0205281 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0025663 (UMLS CUI [1,2])
C0025663 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C1706244 (UMLS CUI-2)
C0430400 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0011008 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,2])
C0029235 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C1706244 (UMLS CUI-2)
C0003204 (UMLS CUI-3)
C1706244 (UMLS CUI-2)
C0003204 (UMLS CUI-3)
C0302350 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C1879316 (UMLS CUI-2)
C0456388 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0079809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0079809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C2346576 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])