ID
42090
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 (1)
- 01-04-21 01-04-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
1 april 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 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.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758
Long-Term Follow-Up for Survival and Disease Status; Patient Withdrawal from Study; Notification of Patient Death; Clarification Form
Beschrijving
Long-Term Follow-Up for Survival and Disease Status
Alias
- UMLS CUI-1
- C1517942
- UMLS CUI-2
- C1148433
- UMLS CUI-3
- C0699749
Beschrijving
Patient status
Datatype
integer
Alias
- UMLS CUI [1]
- C0449437
Beschrijving
Date last known alive
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0038952
Beschrijving
Date of last contact
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
Beschrijving
How was contact made?
Datatype
integer
Alias
- UMLS CUI [1]
- C1705415
Beschrijving
Specify other contact
Datatype
text
Alias
- UMLS CUI [1,1]
- C1705415
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
If Yes, please complete Response Evaluation forms.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C0521982
- UMLS CUI [1,3]
- C0549178
Beschrijving
If Yes, please specify therapy and start date(s) and number of cycles in "Comments" section at bottom of page)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0024305
- UMLS CUI [1,2]
- C1706712
- UMLS CUI [2]
- C0768182
Beschrijving
Has the patient had a documented new diagnosis of myelodysplasia?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0026985
- UMLS CUI [1,2]
- C0011900
Beschrijving
If yes, date of diagnosis (myelodysplasia)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0026985
- UMLS CUI [1,2]
- C2316983
Beschrijving
Has the patient had a new diagnosis of another malignancy?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C0011900
Beschrijving
If yes, date of diagnosis (another malignancy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C2316983
Beschrijving
Is the patient taking thyroid medication?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0040128
- UMLS CUI [1,2]
- C0013227
Beschrijving
If Yes, drug name (thyroid medication)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0040128
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C2360065
Beschrijving
Start date (thyroid medication)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0040128
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0808070
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Signature of Investigator
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Signature of Investigator Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Patient Withdrawal from Study
Alias
- UMLS CUI-1
- C0422727
Beschrijving
Date of withdrawal from study
Datatype
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0011008
Beschrijving
Check primary reason only
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Beschrijving
Specify other reason for withdrawal from study
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Explanation of withdrawal (when appropriate)
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0681841
Beschrijving
Notification of Patient Death
Alias
- UMLS CUI-1
- C0422202
- UMLS CUI-2
- C0011065
Beschrijving
Date of death
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
Check one
Datatype
integer
Alias
- UMLS CUI [1]
- C0007465
Beschrijving
Specify other cause of death
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C2348235
Beschrijving
If cause of death was related to complications of treatment, please describe or reference forms on which information is recorded
Datatype
text
Alias
- UMLS CUI [1]
- C0007465
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C0009566
- UMLS CUI [2,3]
- C0869014
- UMLS CUI [3]
- C0678257
Beschrijving
Relationship of study drug to patient's death
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0011065
- UMLS CUI [1,3]
- C0439849
Beschrijving
Check allt hat apply
Datatype
integer
Alias
- UMLS CUI [1]
- C0011065
- UMLS CUI [2]
- C0683836
Beschrijving
Specify other source of information concerning death of patient
Datatype
text
Alias
- UMLS CUI [1]
- C0011065
- UMLS CUI [2]
- C0683836
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C2348235
Beschrijving
Clarification Form
Alias
- UMLS CUI-1
- C2986669
Beschrijving
Form Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1301746
- UMLS CUI [1,2]
- C0237753
Beschrijving
Series Page Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205549
- UMLS CUI [1,2]
- C1704732
- UMLS CUI [1,3]
- C0237753
Beschrijving
Clearly identify the item to which the comment applies (e.g. date, time, etc.)
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Long-Term Follow-Up for Survival and Disease Status; Patient Withdrawal from Study; Notification of Patient Death; Clarification Form
C0237753 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
C1148433 (UMLS CUI-2)
C0699749 (UMLS CUI-3)
C1517741 (UMLS CUI [1,2])
C0038952 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0521982 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1706712 (UMLS CUI [1,2])
C0768182 (UMLS CUI [2])
C0011900 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0681841 (UMLS CUI [1,2])
C0011065 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0009566 (UMLS CUI [2,2])
C0869014 (UMLS CUI [2,3])
C0678257 (UMLS CUI [3])
C0011065 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0683836 (UMLS CUI [2])
C0683836 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
C0237753 (UMLS CUI [1,2])
C1704732 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])