Informações:
Falhas:
ID
30258
Descrição
https://clinicaltrials.gov/show/NCT00989664 HAMA Results and Follow up - Physical Examination, Laboratory tests and Post-Treatment Response 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
Palavras-chave
Versões (1)
- 25/05/2018 25/05/2018 -
Titular dos direitos
GlaxoSmithKline (GSK)
Transferido a
25 de maio de 2018
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664
HAMA Results and Follow up - Physical Examination, Laboratory tests and Post-Treatment Response
Similar models
HAMA Results and Follow up - Physical Examination, Laboratory tests and Post-Treatment Response
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1,1])
C1291910 (UMLS CUI [1,2])
C1291910 (UMLS CUI [1,2])
CL Item
Week 7 (1)
CL Item
Week 13 (2)
CL Item
Week 25 (3)
Visit - other Week
Item
Visit
integer
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0439230 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Please check the appropriate visit week:
integer
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,2])
CL Item
Week 52 (1 year) (1)
CL Item
Week 78 (1,5 years) (2)
CL Item
Week 104 (2 years) (3)
CL Item
other Week (4)
Other Week
Item
Visit - Other week
integer
C0439230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
"B" Symptoms
Item
Does the patient currently have evidence of "B" symptoms?
boolean
C1706867 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Item
If yes, please check current "B" symptoms
integer
C1706867 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
CL Item
Night sweats (1)
CL Item
Intermittent fevers (2)
CL Item
Weight loss (3)
Date of physical examination
Item
Date of physical examination
date
C2826643 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Karnofsky Status
Item
Karnofsky Status
integer
C0206065 (UMLS CUI [1])
Respirations
Item
Respirations
integer
C0035203 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
CL Item
1. General Appearance (1)
CL Item
2. Skin (2)
CL Item
3. HEENT (3)
CL Item
4. Neck (4)
CL Item
5. Lymph Nodes (5)
CL Item
6. Lungs (6)
CL Item
7. Heart (7)
CL Item
8. Neurological (8)
CL Item
9. Genitourinary (9)
CL Item
10. Abdomen (10)
CL Item
11. Musculoskeletal (11)
CL Item
12. Other (12)
Item
Examination finding
integer
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
CL Item
Not Done (1)
CL Item
Normal (2)
CL Item
Abnormal (3)
If abnormal, specify:
Item
If abnormal, specify:
text
C2826279 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item Group
Laboratory Results - Hematology/Chemistry
C1254595 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
C1254595 (UMLS CUI-4)
C0018943 (UMLS CUI-5)
C0005774 (UMLS CUI-2)
C1254595 (UMLS CUI-4)
C0018943 (UMLS CUI-5)
Hematology Date
Item
Hematology Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Lab # (Worksheet B)
Item
Lab # (Worksheet B)
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hemoglobin (3)
CL Item
Hematocrit (4)
CL Item
Platelets (5)
CL Item
Neutrophils (sears + bands) (6)
CL Item
Lymphocytes (7)
CL Item
Monocytes (8)
CL Item
Eosinophils (9)
CL Item
Basophils (10)
CL Item
Other differential (11)
CL Item
ANC (10³/mm³) (12)
Hematologic test results
Item
Hematologic test results
float
C1254595 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0205488 (UMLS CUI [1,2])
Chemistry Date
Item
Chemistry Date
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Lab # (Worksheet B)
Item
Lab # (Worksheet B)
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
BUN (4)
CL Item
Creatinine (5)
CL Item
AST (SGOT) (6)
CL Item
Alkaline Phosphatase (7)
CL Item
LDH (8)
CL Item
Total Bilirubin (9)
CL Item
TSH (10)
CL Item
Total T3 (11)
CL Item
Free T4 (12)
Chemistry test results
Item
Chemistry test results
float
C1254595 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C0005774 (UMLS CUI [1,2])
Item Group
CT or other Radiological Imaging Results
C0011923 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C1274040 (UMLS CUI-2)
CL Item
Head/Neck (1)
CL Item
Chest (2)
CL Item
Abdomen (3)
CL Item
Pelvis (4)
CL Item
Other (5)
Not done
Item
Not done?
boolean
C0011923 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
Date
Item
Date
date
C0011923 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Radiological Imaging Method
integer
C0011923 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C1275506 (UMLS CUI [1,2])
CL Item
CT (1)
CL Item
MRI (2)
CL Item
X-Ray (3)
CL Item
Other (4)
Other Imaging
Item
Specify other Imaging:
text
C0011923 (UMLS CUI [1,1])
C0079595 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0079595 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal (2)
Abnormal Finding
Item
Specify Abnormal Finding
text
C2826279 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,2])
Date of biopsy
Item
Date of biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,2])
CL Item
1 Normal (1)
CL Item
1 Hypercellular (2)
CL Item
2 Hypocellular (3)
Tumor involvement
Item
Tumor involvement
integer
C1517677 (UMLS CUI [1])
CL Item
Unilateral (1)
CL Item
Bilateral (2)
Item
Bone Marrow Biopsie not done/indicated?
integer
C0005957 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
CL Item
Not done (1)
CL Item
Not indicated (BM not positive at baseline) (2)
CL Item
Not indicated (patient not in CR} (3)
Item Group
Measurable Lymphoma Disease
C0024299 (UMLS CUI-1)
C1513041 (UMLS CUI-2)
C1513041 (UMLS CUI-2)
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1148554 (UMLS CUI [1,2])
C1148554 (UMLS CUI [1,2])
Tumor Measurements
Item
Tumor Measurements
integer
C0205485 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1300072 (UMLS CUI [1,3])
C0242485 (UMLS CUI [1,2])
C1300072 (UMLS CUI [1,3])
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1148554 (UMLS CUI [1,2])
C1148554 (UMLS CUI [1,2])
Item
Status of Non-Measurable Disease
text
C0449438 (UMLS CUI [1,1])
C1334988 (UMLS CUI [1,2])
C1334988 (UMLS CUI [1,2])
CL Item
New (1)
CL Item
Increased (2)
CL Item
Stable (3)
CL Item
Decreased (4)
CL Item
CR (1)
CL Item
CCR (2)
CL Item
PR (3)
CL Item
SD (4)
CL Item
PD (5)
Date of Response Evaluation
Item
Date of Response Evaluation
date
C1704632 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Signature of Investigator
Item
Signature of Investigator
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])