ID

36921

Description

Ph 2 Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC; ODM derived from: https://clinicaltrials.gov/show/NCT02463799

Lien

https://clinicaltrials.gov/show/NCT02463799

Mots-clés

Versions (2)
  1. 21/06/2019 21/06/2019 -
  2. 21/06/2019 21/06/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

21 juin 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02463799

Anglais

Eligibility Prostate Cancer NCT02463799

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent provided prior to initiation of study procedures
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
2. age ≥ 18 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen. if prostatic tumor is of mixed histology, > 50% of the tumor must be adenocarcinoma
Description

Adenocarcinoma of prostate Biopsy of prostate | Specimen from prostate obtained by radical prostatectomy | Prostate carcinoma Histology Mixed | Neoplasm Percentage Adenocarcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0194804
UMLS CUI [2]
C1292667
UMLS CUI [3,1]
C0600139
UMLS CUI [3,2]
C0344441
UMLS CUI [3,3]
C0205430
UMLS CUI [4,1]
C0027651
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C0001418
4. bone metastases as manifested by one or more lesions on a bone scan performed within 2 months of screening
Description

Secondary malignant neoplasm of bone | Lesion Quantity Bone scan

Type de données

boolean

Alias
UMLS CUI [1]
C0153690
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0203668
5. castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (≤ 50 ng/dl), defined as current or historical evidence of disease progression concomitant with surgical castration or androgen deprivation therapy (adt), as demonstrated by two consecutive rises in psa or new lesions on bone scan:
Description

Hormone refractory prostate cancer | Castration Levels of Testosterone Testosterone measurement | Disease Progression | Male Castration | Antiandrogen therapy | Raised prostate specific antigen Quantity | Lesion New Bone scan

Type de données

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2,1]
C4289828
UMLS CUI [2,2]
C0523912
UMLS CUI [3]
C0242656
UMLS CUI [4]
C0007347
UMLS CUI [5]
C0279492
UMLS CUI [6,1]
C0178415
UMLS CUI [6,2]
C1265611
UMLS CUI [7,1]
C0221198
UMLS CUI [7,2]
C0205314
UMLS CUI [7,3]
C0203668
psa progression will be defined as 2 rising psa values compared to a reference value, measured at least 7 days apart and the second value is ≥ 2 ng/ml [1]. it must be documented within 2 months of screening.
Description

Raised prostate specific antigen Result Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1265611
appearance of one or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response. increased uptake of pre-existing lesions on bone scan does not constitute progression. it must be documented within 4 months of screening
Description

Abnormal results of radionuclide uptake studies Bone scan | Imaging studies During Castration | Imaging studies Before Castration | Lesion Pre-existing Bone scan

Type de données

boolean

Alias
UMLS CUI [1,1]
C4290294
UMLS CUI [1,2]
C0203668
UMLS CUI [2,1]
C1881134
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0007344
UMLS CUI [3,1]
C1881134
UMLS CUI [3,2]
C0332152
UMLS CUI [3,3]
C0007344
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C2347662
UMLS CUI [4,3]
C0203668
6. serum psa ≥ 2.0 ng/ml
Description

Prostate specific antigen measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201544
7. screening ecog perf status ≤ 1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
8. asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed)
Description

Asymptomatic Diseases | Disease Minimal Symptomatic | Narcotic Analgesics Absent | Analgesics

Type de données

boolean

Alias
UMLS CUI [1]
C2936329
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0547040
UMLS CUI [2,3]
C0231220
UMLS CUI [3,1]
C0027409
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0002771
9. prior abiraterone and enzalutamide are permitted, but not required
Description

abiraterone | enzalutamide

Type de données

boolean

Alias
UMLS CUI [1]
C0754011
UMLS CUI [2]
C3496793
10. concurrent osteoclast-inhibitory therapies (zoledronic acid, denosumab) are permitted if patients have been on a stable dose for at least 1 month
Description

Osteoclast inhibitors Dose Stable | zoledronic acid | denosumab

Type de données

boolean

Alias
UMLS CUI [1,1]
C3161558
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0257685
UMLS CUI [3]
C1690432
11. adequate screening hematologic, renal, and liver function as evidenced by laboratory test results within the following ranges ≤ 28 days prior to registration:
Description

Hematologic function Laboratory test result | Renal function Laboratory test result | Liver function Laboratory test result

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0587081
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0587081
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0587081
absolute neutrophil count (anc) ≥ 1.5 x109/l
Description

Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100 x109/l
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥ 10.0 g/dl
Description

Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
total bilirubin level ≤ 1.5 x institutional upper limit of normal (uln)
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinine ≤ 1.5 x uln
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
albumin > 25 g/l
Description

Albumin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201838
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the presence of known lung or liver metastases greater than 1.0 cm in the long axis diameter
Description

Secondary malignant neoplasm of lung Diameter Long axis | Secondary malignant neoplasm of liver Diameter Long axis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0153676
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0522487
UMLS CUI [2,1]
C0494165
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0522487
2. the presence of lymphadenopathy greater than 3 cm in the short-axis diameter
Description

Lymphadenopathy Diameter Short axis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0522488
3. the presence of known brain metastases
Description

Metastatic malignant neoplasm to brain

Type de données

boolean

Alias
UMLS CUI [1]
C0220650
4. spinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phase
Description

Compression of spinal cord | Fractures of the long bones Impending | Condition Requirement Therapeutic radiology procedure | Requirement Steroids Pain control

Type de données

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2,1]
C0240231
UMLS CUI [2,2]
C0332190
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C1522449
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0038317
UMLS CUI [4,3]
C1304888
5. previous treatment with chemotherapy for mcrpc (adjuvant chemotherapy is permitted), or chemotherapy for any reason within 2 years prior to registration
Description

Chemotherapy Castration-Resistant Prostatic Cancer metastatic | Chemotherapy, Adjuvant | Chemotherapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C3658266
UMLS CUI [1,3]
C1522484
UMLS CUI [2]
C0085533
UMLS CUI [3]
C0392920
6. intention to receive chemotherapy within 6 months after enrollment in protocol therapy
Description

Chemotherapy intended

Type de données

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C1283828
7. history of radiation therapy, either via external beam or brachytherapy within 28 days prior to registration
Description

Therapeutic radiology procedure | Teleradiotherapy procedure | Brachytherapy

Type de données

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0419095
UMLS CUI [3]
C0006098
8. systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
Description

Systemic Radiation Therapy Secondary malignant neoplasm of bone | Strontium-89 | Samarium 153 | Rhenium-186 | Rhenium-188

Type de données

boolean

Alias
UMLS CUI [1,1]
C2985381
UMLS CUI [1,2]
C0153690
UMLS CUI [2]
C0281385
UMLS CUI [3]
C0677942
UMLS CUI [4]
C0361302
UMLS CUI [5]
C1828331
9. prior history of other cancers (except non-melanoma skin cancers or low-grade low-stage urothelial cancers)
Description

Cancer Other | Exception Skin carcinoma | Exception Transitional Cell Carcinoma low grade

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007138
UMLS CUI [3,3]
C1282907
10. use of prednisone or equivalent systemic corticosteroid within 2 weeks of treatment. use of inhaled, intranasal, intra-articular, and topical steroids is allowed. oral or iv steroids to prevent or treat iv contrast reactions are allowed
Description

Prednisone | Systemic Corticosteroid Equivalent

Type de données

boolean

Alias
UMLS CUI [1]
C0032952
UMLS CUI [2,1]
C4053960
UMLS CUI [2,2]
C0205163
11. use of opioid analgesics for cancer-related pain
Description

Opioid Analgesics Cancer Pain

Type de données

boolean

Alias
UMLS CUI [1,1]
C0002772
UMLS CUI [1,2]
C0596240
12. use of experimental drug within 4 weeks of treatment
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
13. uncontrolled medical conditions including diabetes, heart failure, copd, ulcerative colitis, or crohn's disease
Description

Medical condition Uncontrolled | Diabetes Mellitus | Heart failure | Chronic Obstructive Airway Disease | Ulcerative Colitis | Crohn Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0024117
UMLS CUI [5]
C0009324
UMLS CUI [6]
C0010346
14. uncontrolled fecal incontinence
Description

Fecal Incontinence Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0015732
UMLS CUI [1,2]
C0205318
15. any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives
Description

Intervention compromises Protocol Compliance | Intervention compromises Clinical Trial | Condition compromises Protocol Compliance | Condition compromises Clinical Trial | Circumstances compromise Protocol Compliance | Circumstances compromise Clinical Trial

Type de données

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C0008976
UMLS CUI [5,1]
C0680082
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0680082
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C0008976
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Similar models

Eligibility Prostate Cancer NCT02463799

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent provided prior to initiation of study procedures
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate Biopsy of prostate | Specimen from prostate obtained by radical prostatectomy | Prostate carcinoma Histology Mixed | Neoplasm Percentage Adenocarcinoma
Item
3. histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen. if prostatic tumor is of mixed histology, > 50% of the tumor must be adenocarcinoma
boolean
C0007112 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
C1292667 (UMLS CUI [2])
C0600139 (UMLS CUI [3,1])
C0344441 (UMLS CUI [3,2])
C0205430 (UMLS CUI [3,3])
C0027651 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0001418 (UMLS CUI [4,3])
Secondary malignant neoplasm of bone | Lesion Quantity Bone scan
Item
4. bone metastases as manifested by one or more lesions on a bone scan performed within 2 months of screening
boolean
C0153690 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0203668 (UMLS CUI [2,3])
Hormone refractory prostate cancer | Castration Levels of Testosterone Testosterone measurement | Disease Progression | Male Castration | Antiandrogen therapy | Raised prostate specific antigen Quantity | Lesion New Bone scan
Item
5. castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (≤ 50 ng/dl), defined as current or historical evidence of disease progression concomitant with surgical castration or androgen deprivation therapy (adt), as demonstrated by two consecutive rises in psa or new lesions on bone scan:
boolean
C1328504 (UMLS CUI [1])
C4289828 (UMLS CUI [2,1])
C0523912 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
C0007347 (UMLS CUI [4])
C0279492 (UMLS CUI [5])
C0178415 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0221198 (UMLS CUI [7,1])
C0205314 (UMLS CUI [7,2])
C0203668 (UMLS CUI [7,3])
Raised prostate specific antigen Result Quantity
Item
psa progression will be defined as 2 rising psa values compared to a reference value, measured at least 7 days apart and the second value is ≥ 2 ng/ml [1]. it must be documented within 2 months of screening.
boolean
C0178415 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Abnormal results of radionuclide uptake studies Bone scan | Imaging studies During Castration | Imaging studies Before Castration | Lesion Pre-existing Bone scan
Item
appearance of one or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response. increased uptake of pre-existing lesions on bone scan does not constitute progression. it must be documented within 4 months of screening
boolean
C4290294 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C1881134 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0007344 (UMLS CUI [2,3])
C1881134 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0007344 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C2347662 (UMLS CUI [4,2])
C0203668 (UMLS CUI [4,3])
Prostate specific antigen measurement
Item
6. serum psa ≥ 2.0 ng/ml
boolean
C0201544 (UMLS CUI [1])
ECOG performance status
Item
7. screening ecog perf status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Asymptomatic Diseases | Disease Minimal Symptomatic | Narcotic Analgesics Absent | Analgesics
Item
8. asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed)
boolean
C2936329 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C0027409 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0002771 (UMLS CUI [4])
abiraterone | enzalutamide
Item
9. prior abiraterone and enzalutamide are permitted, but not required
boolean
C0754011 (UMLS CUI [1])
C3496793 (UMLS CUI [2])
Osteoclast inhibitors Dose Stable | zoledronic acid | denosumab
Item
10. concurrent osteoclast-inhibitory therapies (zoledronic acid, denosumab) are permitted if patients have been on a stable dose for at least 1 month
boolean
C3161558 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0257685 (UMLS CUI [2])
C1690432 (UMLS CUI [3])
Hematologic function Laboratory test result | Renal function Laboratory test result | Liver function Laboratory test result
Item
11. adequate screening hematologic, renal, and liver function as evidenced by laboratory test results within the following ranges ≤ 28 days prior to registration:
boolean
C0221130 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0587081 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C0587081 (UMLS CUI [3,2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥ 1.5 x109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100 x109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 10.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin level ≤ 1.5 x institutional upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatinine ≤ 1.5 x uln
boolean
C0201976 (UMLS CUI [1])
Albumin measurement
Item
albumin > 25 g/l
boolean
C0201838 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of lung Diameter Long axis | Secondary malignant neoplasm of liver Diameter Long axis
Item
1. the presence of known lung or liver metastases greater than 1.0 cm in the long axis diameter
boolean
C0153676 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0522487 (UMLS CUI [1,3])
C0494165 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0522487 (UMLS CUI [2,3])
Lymphadenopathy Diameter Short axis
Item
2. the presence of lymphadenopathy greater than 3 cm in the short-axis diameter
boolean
C0497156 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0522488 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain
Item
3. the presence of known brain metastases
boolean
C0220650 (UMLS CUI [1])
Compression of spinal cord | Fractures of the long bones Impending | Condition Requirement Therapeutic radiology procedure | Requirement Steroids Pain control
Item
4. spinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phase
boolean
C0037926 (UMLS CUI [1])
C0240231 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
C0348080 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C1304888 (UMLS CUI [4,3])
Chemotherapy Castration-Resistant Prostatic Cancer metastatic | Chemotherapy, Adjuvant | Chemotherapy
Item
5. previous treatment with chemotherapy for mcrpc (adjuvant chemotherapy is permitted), or chemotherapy for any reason within 2 years prior to registration
boolean
C0392920 (UMLS CUI [1,1])
C3658266 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
Chemotherapy intended
Item
6. intention to receive chemotherapy within 6 months after enrollment in protocol therapy
boolean
C3665472 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
Therapeutic radiology procedure | Teleradiotherapy procedure | Brachytherapy
Item
7. history of radiation therapy, either via external beam or brachytherapy within 28 days prior to registration
boolean
C1522449 (UMLS CUI [1])
C0419095 (UMLS CUI [2])
C0006098 (UMLS CUI [3])
Systemic Radiation Therapy Secondary malignant neoplasm of bone | Strontium-89 | Samarium 153 | Rhenium-186 | Rhenium-188
Item
8. systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
boolean
C2985381 (UMLS CUI [1,1])
C0153690 (UMLS CUI [1,2])
C0281385 (UMLS CUI [2])
C0677942 (UMLS CUI [3])
C0361302 (UMLS CUI [4])
C1828331 (UMLS CUI [5])
Cancer Other | Exception Skin carcinoma | Exception Transitional Cell Carcinoma low grade
Item
9. prior history of other cancers (except non-melanoma skin cancers or low-grade low-stage urothelial cancers)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007138 (UMLS CUI [3,2])
C1282907 (UMLS CUI [3,3])
Prednisone | Systemic Corticosteroid Equivalent
Item
10. use of prednisone or equivalent systemic corticosteroid within 2 weeks of treatment. use of inhaled, intranasal, intra-articular, and topical steroids is allowed. oral or iv steroids to prevent or treat iv contrast reactions are allowed
boolean
C0032952 (UMLS CUI [1])
C4053960 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Opioid Analgesics Cancer Pain
Item
11. use of opioid analgesics for cancer-related pain
boolean
C0002772 (UMLS CUI [1,1])
C0596240 (UMLS CUI [1,2])
Investigational New Drugs
Item
12. use of experimental drug within 4 weeks of treatment
boolean
C0013230 (UMLS CUI [1])
Medical condition Uncontrolled | Diabetes Mellitus | Heart failure | Chronic Obstructive Airway Disease | Ulcerative Colitis | Crohn Disease
Item
13. uncontrolled medical conditions including diabetes, heart failure, copd, ulcerative colitis, or crohn's disease
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
C0010346 (UMLS CUI [6])
Fecal Incontinence Uncontrolled
Item
14. uncontrolled fecal incontinence
boolean
C0015732 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Intervention compromises Protocol Compliance | Intervention compromises Clinical Trial | Condition compromises Protocol Compliance | Condition compromises Clinical Trial | Circumstances compromise Protocol Compliance | Circumstances compromise Clinical Trial
Item
15. any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives
boolean
C0184661 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
C0680082 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0680082 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C0008976 (UMLS CUI [6,3])
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