ID

42592

Beschrijving

BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02278978

Link

https://clinicaltrials.gov/show/NCT02278978

Trefwoorden

Versies (1)
  1. 15-09-21 15-09-21 -
Houder van rechten

National Taiwan University Hospital

Geüploaded op

15 september 2021

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Urothelial Carcinoma NCT02278978

Engels

Eligibility Urothelial Carcinoma NCT02278978

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
kps 60%
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
histological confirmation of urothelial carcinoma , with metastatic disease
Beschrijving

Urothelial carcinoma | Neoplasm metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C1519840
UMLS CUI [2]
C0027627
measurable disease
Beschrijving

Measurable disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
previously treated with platinum-based chemotherapy administered
Beschrijving

Prior therapy with platinum-based chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C1514463
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiographic evidence of cavitary or necrotic tumours
Beschrijving

Radiographic evidence of cavitary tumors | Radiographic evidence of necrotic tumours

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1510420
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C1300818
UMLS CUI [2,2]
C0034571
active brain metastasis.leptomeningeal metastasis
Beschrijving

Active brain metastasis | Leptomeningeal metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205177
UMLS CUI [2]
C1704231
chemotherapy, radiotherapy, targeted therapy with monoclonal antibodies or small tyrosine kinase inhibitors
Beschrijving

Chemotherapy | Radiotherapy | Targeted therapy with monoclonal antibodies | Targeted therapy with small tyrosine kinase inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C0003250
UMLS CUI [4,1]
C2985566
UMLS CUI [4,2]
C1268567
grade 1 treatment-related toxicity from previous chemotherapy, radiotherapy, or targeted therapy
Beschrijving

Grade 1 treatment-related toxicity from previous chemotherapy, radiotherapy, or targeted therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2826262
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0877248
UMLS CUI [2,3]
C2826262
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C0877248
UMLS CUI [3,3]
C2826262
prior treatment with bibf 1120 or other vegfr inhibitors
Beschrijving

Prior therapy with nintedanib | Prior therapy with other VEGFR inhibitor

Datatype

boolean

Alias
UMLS CUI [1,1]
C2930789
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C2985521
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C2930789
UMLS CUI [2,4]
C1705847
significant cardiovascular diseases:
Beschrijving

Significant cardiovascular diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0750502
pericardial effusion
Beschrijving

Pericardial effusion

Datatype

boolean

Alias
UMLS CUI [1]
C0031039
significant bleeding or thrombosis
Beschrijving

Significant bleeding | Significant thrombosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0040053
UMLS CUI [2,2]
C0750502
gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
Beschrijving

gGstrointestinal disorders or abnormalities that would interfere with absorption of the experimental drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0237442
UMLS CUI [2,1]
C4023588
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0304229
UMLS CUI [2,4]
C0237442
major injuries within the past 10 days with incomplete wound healing and/or planned surgery during the on-treatment study period
Beschrijving

Recent major injuries that would interfere with wound healing | Surgery planned during the study period

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332677
UMLS CUI [1,2]
C0151692
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0008976
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Similar models

Eligibility Urothelial Carcinoma NCT02278978

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Karnofsky Performance Status
Item
kps 60%
boolean
C0206065 (UMLS CUI [1])
Urothelial carcinoma | Neoplasm metastasis
Item
histological confirmation of urothelial carcinoma , with metastatic disease
boolean
C1519840 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Measurable disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Prior therapy with platinum-based chemotherapy
Item
previously treated with platinum-based chemotherapy administered
boolean
C0392920 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Radiographic evidence of cavitary tumors | Radiographic evidence of necrotic tumours
Item
radiographic evidence of cavitary or necrotic tumours
boolean
C0027651 (UMLS CUI [1,1])
C1510420 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C1300818 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
Active brain metastasis | Leptomeningeal metastasis
Item
active brain metastasis.leptomeningeal metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2])
Chemotherapy | Radiotherapy | Targeted therapy with monoclonal antibodies | Targeted therapy with small tyrosine kinase inhibitors
Item
chemotherapy, radiotherapy, targeted therapy with monoclonal antibodies or small tyrosine kinase inhibitors
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C2985566 (UMLS CUI [3,1])
C0003250 (UMLS CUI [3,2])
C2985566 (UMLS CUI [4,1])
C1268567 (UMLS CUI [4,2])
Grade 1 treatment-related toxicity from previous chemotherapy, radiotherapy, or targeted therapy
Item
grade 1 treatment-related toxicity from previous chemotherapy, radiotherapy, or targeted therapy
boolean
C0392920 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C2826262 (UMLS CUI [2,3])
C2985566 (UMLS CUI [3,1])
C0877248 (UMLS CUI [3,2])
C2826262 (UMLS CUI [3,3])
Prior therapy with nintedanib | Prior therapy with other VEGFR inhibitor
Item
prior treatment with bibf 1120 or other vegfr inhibitors
boolean
C2930789 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C2985521 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C2930789 (UMLS CUI [2,3])
C1705847 (UMLS CUI [2,4])
Significant cardiovascular diseases
Item
significant cardiovascular diseases:
boolean
C0007222 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Pericardial effusion
Item
pericardial effusion
boolean
C0031039 (UMLS CUI [1])
Significant bleeding | Significant thrombosis
Item
significant bleeding or thrombosis
boolean
C0019080 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0040053 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
gGstrointestinal disorders or abnormalities that would interfere with absorption of the experimental drug
Item
gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0237442 (UMLS CUI [1,4])
C4023588 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,3])
C0237442 (UMLS CUI [2,4])
Recent major injuries that would interfere with wound healing | Surgery planned during the study period
Item
major injuries within the past 10 days with incomplete wound healing and/or planned surgery during the on-treatment study period
boolean
C0332677 (UMLS CUI [1,1])
C0151692 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
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