ID
42090
Beschreibung
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
Stichworte
Versionen (1)
- 01.04.21 01.04.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
1. April 2021
DOI
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Lizenz
Creative Commons BY 4.0
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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
Beschreibung
Long-Term Follow-Up for Survival and Disease Status
Alias
- UMLS CUI-1
- C1517942
- UMLS CUI-2
- C1148433
- UMLS CUI-3
- C0699749
Beschreibung
Patient status
Datentyp
integer
Alias
- UMLS CUI [1]
- C0449437
Beschreibung
Date last known alive
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0038952
Beschreibung
Date of last contact
Datentyp
date
Alias
- UMLS CUI [1]
- C0805839
Beschreibung
How was contact made?
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705415
Beschreibung
Specify other contact
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1705415
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
If Yes, please complete Response Evaluation forms.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C0521982
- UMLS CUI [1,3]
- C0549178
Beschreibung
If Yes, please specify therapy and start date(s) and number of cycles in "Comments" section at bottom of page)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0024305
- UMLS CUI [1,2]
- C1706712
- UMLS CUI [2]
- C0768182
Beschreibung
Has the patient had a documented new diagnosis of myelodysplasia?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0026985
- UMLS CUI [1,2]
- C0011900
Beschreibung
If yes, date of diagnosis (myelodysplasia)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0026985
- UMLS CUI [1,2]
- C2316983
Beschreibung
Has the patient had a new diagnosis of another malignancy?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C0011900
Beschreibung
If yes, date of diagnosis (another malignancy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C2316983
Beschreibung
Is the patient taking thyroid medication?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040128
- UMLS CUI [1,2]
- C0013227
Beschreibung
If Yes, drug name (thyroid medication)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0040128
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C2360065
Beschreibung
Start date (thyroid medication)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0040128
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0808070
Beschreibung
Comments
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Signature of Investigator
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Signature of Investigator Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Patient Withdrawal from Study
Alias
- UMLS CUI-1
- C0422727
Beschreibung
Date of withdrawal from study
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0011008
Beschreibung
Check primary reason only
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Beschreibung
Specify other reason for withdrawal from study
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschreibung
Explanation of withdrawal (when appropriate)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0681841
Beschreibung
Notification of Patient Death
Alias
- UMLS CUI-1
- C0422202
- UMLS CUI-2
- C0011065
Beschreibung
Date of death
Datentyp
date
Alias
- UMLS CUI [1]
- C1148348
Beschreibung
Check one
Datentyp
integer
Alias
- UMLS CUI [1]
- C0007465
Beschreibung
Specify other cause of death
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C2348235
Beschreibung
If cause of death was related to complications of treatment, please describe or reference forms on which information is recorded
Datentyp
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
Beschreibung
Relationship of study drug to patient's death
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0011065
- UMLS CUI [1,3]
- C0439849
Beschreibung
Check allt hat apply
Datentyp
integer
Alias
- UMLS CUI [1]
- C0011065
- UMLS CUI [2]
- C0683836
Beschreibung
Specify other source of information concerning death of patient
Datentyp
text
Alias
- UMLS CUI [1]
- C0011065
- UMLS CUI [2]
- C0683836
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C2348235
Beschreibung
Clarification Form
Alias
- UMLS CUI-1
- C2986669
Beschreibung
Form Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1301746
- UMLS CUI [1,2]
- C0237753
Beschreibung
Series Page Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205549
- UMLS CUI [1,2]
- C1704732
- UMLS CUI [1,3]
- C0237753
Beschreibung
Clearly identify the item to which the comment applies (e.g. date, time, etc.)
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Ähnliche Modelle
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])