ID

21897

Description

A Study of ATN-224 and Bortezomib in Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00352742

Link

https://clinicaltrials.gov/show/NCT00352742

Keywords

Versions (1)
  1. 5/7/17 5/7/17 -
Uploaded on

May 7, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00352742

English

Eligibility Multiple Myeloma NCT00352742

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed multiple myeloma that has been treated with at least one different prior anti-myeloma regimens including one with bortezomib and is currently showing evidence of progressive disease
Description

Multiple Myeloma | Therapeutic procedure Different Quantity | bortezomib | Progressive Disease Evidence of

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1705242
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C1176309
UMLS CUI [4,1]
C1335499
UMLS CUI [4,2]
C0332120
2. myeloma that is refractory to the most recent bortezomib-containing regimen as demonstrated by progressive disease while on bortezomib or that relapsed within 12 weeks of the last dose of bortezomib either as a single agent or in combination with other agents
Description

Bortezomib | Multiple Myeloma Refractory | Progressive Disease | Combined Modality Therapy | Multiple Myeloma Relapse

Data type

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0205269
UMLS CUI [3]
C1335499
UMLS CUI [4,1]
C1176309
UMLS CUI [4,2]
C0009429
UMLS CUI [5,1]
C0026764
UMLS CUI [5,2]
C0277556
3. measurable disease defined as a serum m-protein concentration on electrophoresis ≥1 g/dl of igg myeloma or ≥0.5 g/dl of iga myeloma or igm myeloma or urinary excretion of monoclonal light chain ≥200 mg/24 hours
Description

Measurable Disease | M Protein serum concentration Electrophoresis | IgG myeloma | IgA myeloma | Multiple Myeloma-IgM | Monoclonal free light chain present In Urine

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C0683149
UMLS CUI [2,3]
C0013855
UMLS CUI [3]
C0563306
UMLS CUI [4]
C0563305
UMLS CUI [5]
C2347304
UMLS CUI [6,1]
C1532998
UMLS CUI [6,2]
C0042037
4. age >18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. life expectancy of greater than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
6. ecog performance status <2 (karnofsky >60%; see appendix a)
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
7. adequate organ and marrow function as defined below:
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
absolute neutrophil count ≥1,000/ul
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≥75,000/ul
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥8 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
total bilirubin ≤2 x institutional upper limit of normal (uln)
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
ast(sgot) and alt(sgpt) ≤3 x uln
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinine clearance ≥30 ml/min (measured or calculated)
Description

Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C2711451
patients are allowed to receive blood transfusions before receiving their first dose of atn-224 to bring the hemoglobin level to ≥8 g/dl to meet eligibility criteria.
Description

Blood Transfusion | ATN-224 | Hemoglobin level

Data type

boolean

Alias
UMLS CUI [1]
C0005841
UMLS CUI [2]
C1831930
UMLS CUI [3]
C0019029
8. use of adequate contraception. the effects of atn 224 on the developing human fetus at the recommended therapeutic dose are unknown. for this reason and because antiangiogenic agents are known to be teratogenic, women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation through the follow up visit 28 days after the last dose of atn 224.
Description

Contraceptive methods | ATN-224 | Angiogenesis Inhibitors Associated with Teratogenic effects | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C1831930
UMLS CUI [3,1]
C0596087
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0232910
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
UMLS CUI [6]
C2985296
UMLS CUI [7]
C0004764
UMLS CUI [8]
C0036899
9. willingness to forego taking copper- or zinc-containing vitamins or supplements
Description

Vitamins Copper Intake Willing | Vitamins Zinc Intake Willing | Vitamin supplement Intake Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0042890
UMLS CUI [1,2]
C0009968
UMLS CUI [1,3]
C1512806
UMLS CUI [1,4]
C0600109
UMLS CUI [2,1]
C0042890
UMLS CUI [2,2]
C0043481
UMLS CUI [2,3]
C1512806
UMLS CUI [2,4]
C0600109
UMLS CUI [3,1]
C0681579
UMLS CUI [3,2]
C1512806
UMLS CUI [3,3]
C0600109
10. ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) or thalidomide, lenalidomide, dexamethasone, arsenic trioxide, bortezomib, or glucocorticosteroids within 3 weeks prior to the first dose of atn-224 or failure to recover from reversible adverse events due to agents administered previously
Description

Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin-c | Thalidomide | lenalidomide | Dexamethasone | arsenic trioxide | bortezomib | Glucocorticoids | Adverse event Reversible Due to Pharmaceutical Preparations | Recovery failed

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5]
C0039736
UMLS CUI [6]
C1144149
UMLS CUI [7]
C0011777
UMLS CUI [8]
C0052416
UMLS CUI [9]
C1176309
UMLS CUI [10]
C0017710
UMLS CUI [11,1]
C0877248
UMLS CUI [11,2]
C0205343
UMLS CUI [11,3]
C0678226
UMLS CUI [11,4]
C0013227
UMLS CUI [12,1]
C2004454
UMLS CUI [12,2]
C0231175
2. patients who cannot tolerate, based on previous experience, the assigned dose of bortezomib, including those with ≥ grade 2 neuropathy
Description

Intolerance to Bortezomib Dose | Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1176309
UMLS CUI [1,3]
C0178602
UMLS CUI [2,1]
C0442874
UMLS CUI [2,2]
C1516728
3. concurrent administration of any other investigational agents
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
4. history of malabsorption syndromes or other gastrointestinal disorders that may affect atn-224 absorption, including bowel obstruction, celiac disease, sprue, cystic fibrosis
Description

Malabsorption Syndrome | Gastrointestinal Diseases Affecting ATN-224 Absorption | Intestinal Obstruction | Celiac Disease | Sprue | Cystic Fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1831930
UMLS CUI [2,4]
C0237442
UMLS CUI [3]
C0021843
UMLS CUI [4]
C0007570
UMLS CUI [5]
C0205707
UMLS CUI [6]
C0010674
5. ineligible to receive omeprazole (prilosec® otc) or other long-acting antacid
Description

Omeprazole | Prilosec | Antacids Effective Long-term

Data type

boolean

Alias
UMLS CUI [1]
C0028978
UMLS CUI [2]
C0700777
UMLS CUI [3,1]
C0003138
UMLS CUI [3,2]
C1280519
UMLS CUI [3,3]
C0443252
6. inability to swallow study medication capsules
Description

Able to swallow drug capsule

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
7. not a suitable candidate in the opinion of the investigator for additional bortezomib therapy
Description

bortezomib | Additional Therapy Inappropriate

Data type

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2,1]
C1706712
UMLS CUI [2,2]
C1548788
8. other serious medical or psychiatric illness preventing informed consent or intensive treatment
Description

Illness Serious Preventing Informed Consent | Illness Preventing Therapeutic procedure Intensity | Mental disorder Serious Preventing Informed Consent | Mental disorder Preventing Therapeutic procedure Intensity

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0522510
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C1292733
UMLS CUI [3,4]
C0021430
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0522510
9. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Description

Comorbidity | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
10. women who are pregnant or lactating
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
11. known history of hiv
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
12. history of another prior cancer, except basal cell carcinoma or carcinoma in situ of the cervix (or if there has been no evidence of recurrence for at least 5 years)
Description

Malignant Neoplasms | Recurrent Malignant Neoplasm Evidence Absent | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1458156
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0851140
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Similar models

Eligibility Multiple Myeloma NCT00352742

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Therapeutic procedure Different Quantity | bortezomib | Progressive Disease Evidence of
Item
1. histologically or cytologically confirmed multiple myeloma that has been treated with at least one different prior anti-myeloma regimens including one with bortezomib and is currently showing evidence of progressive disease
boolean
C0026764 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1176309 (UMLS CUI [3])
C1335499 (UMLS CUI [4,1])
C0332120 (UMLS CUI [4,2])
Bortezomib | Multiple Myeloma Refractory | Progressive Disease | Combined Modality Therapy | Multiple Myeloma Relapse
Item
2. myeloma that is refractory to the most recent bortezomib-containing regimen as demonstrated by progressive disease while on bortezomib or that relapsed within 12 weeks of the last dose of bortezomib either as a single agent or in combination with other agents
boolean
C1176309 (UMLS CUI [1])
C0026764 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C1335499 (UMLS CUI [3])
C1176309 (UMLS CUI [4,1])
C0009429 (UMLS CUI [4,2])
C0026764 (UMLS CUI [5,1])
C0277556 (UMLS CUI [5,2])
Measurable Disease | M Protein serum concentration Electrophoresis | IgG myeloma | IgA myeloma | Multiple Myeloma-IgM | Monoclonal free light chain present In Urine
Item
3. measurable disease defined as a serum m-protein concentration on electrophoresis ≥1 g/dl of igg myeloma or ≥0.5 g/dl of iga myeloma or igm myeloma or urinary excretion of monoclonal light chain ≥200 mg/24 hours
boolean
C1513041 (UMLS CUI [1])
C0700271 (UMLS CUI [2,1])
C0683149 (UMLS CUI [2,2])
C0013855 (UMLS CUI [2,3])
C0563306 (UMLS CUI [3])
C0563305 (UMLS CUI [4])
C2347304 (UMLS CUI [5])
C1532998 (UMLS CUI [6,1])
C0042037 (UMLS CUI [6,2])
Age
Item
4. age >18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
5. life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
6. ecog performance status <2 (karnofsky >60%; see appendix a)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Organ function | Bone Marrow function
Item
7. adequate organ and marrow function as defined below:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absolute neutrophil count
Item
absolute neutrophil count ≥1,000/ul
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥75,000/ul
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥8 g/dl
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≤2 x institutional upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast(sgot) and alt(sgpt) ≤3 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance ≥30 ml/min (measured or calculated)
boolean
C0373595 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Blood Transfusion | ATN-224 | Hemoglobin level
Item
patients are allowed to receive blood transfusions before receiving their first dose of atn-224 to bring the hemoglobin level to ≥8 g/dl to meet eligibility criteria.
boolean
C0005841 (UMLS CUI [1])
C1831930 (UMLS CUI [2])
C0019029 (UMLS CUI [3])
Contraceptive methods | ATN-224 | Angiogenesis Inhibitors Associated with Teratogenic effects | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
8. use of adequate contraception. the effects of atn 224 on the developing human fetus at the recommended therapeutic dose are unknown. for this reason and because antiangiogenic agents are known to be teratogenic, women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation through the follow up visit 28 days after the last dose of atn 224.
boolean
C0700589 (UMLS CUI [1])
C1831930 (UMLS CUI [2])
C0596087 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0232910 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C2985296 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C0036899 (UMLS CUI [8])
Vitamins Copper Intake Willing | Vitamins Zinc Intake Willing | Vitamin supplement Intake Willing
Item
9. willingness to forego taking copper- or zinc-containing vitamins or supplements
boolean
C0042890 (UMLS CUI [1,1])
C0009968 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,4])
C0042890 (UMLS CUI [2,1])
C0043481 (UMLS CUI [2,2])
C1512806 (UMLS CUI [2,3])
C0600109 (UMLS CUI [2,4])
C0681579 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
Informed Consent
Item
10. ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin-c | Thalidomide | lenalidomide | Dexamethasone | arsenic trioxide | bortezomib | Glucocorticoids | Adverse event Reversible Due to Pharmaceutical Preparations | Recovery failed
Item
1. chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) or thalidomide, lenalidomide, dexamethasone, arsenic trioxide, bortezomib, or glucocorticosteroids within 3 weeks prior to the first dose of atn-224 or failure to recover from reversible adverse events due to agents administered previously
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0039736 (UMLS CUI [5])
C1144149 (UMLS CUI [6])
C0011777 (UMLS CUI [7])
C0052416 (UMLS CUI [8])
C1176309 (UMLS CUI [9])
C0017710 (UMLS CUI [10])
C0877248 (UMLS CUI [11,1])
C0205343 (UMLS CUI [11,2])
C0678226 (UMLS CUI [11,3])
C0013227 (UMLS CUI [11,4])
C2004454 (UMLS CUI [12,1])
C0231175 (UMLS CUI [12,2])
Intolerance to Bortezomib Dose | Neuropathy CTCAE Grades
Item
2. patients who cannot tolerate, based on previous experience, the assigned dose of bortezomib, including those with ≥ grade 2 neuropathy
boolean
C1744706 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0442874 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Investigational New Drugs
Item
3. concurrent administration of any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Malabsorption Syndrome | Gastrointestinal Diseases Affecting ATN-224 Absorption | Intestinal Obstruction | Celiac Disease | Sprue | Cystic Fibrosis
Item
4. history of malabsorption syndromes or other gastrointestinal disorders that may affect atn-224 absorption, including bowel obstruction, celiac disease, sprue, cystic fibrosis
boolean
C0024523 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1831930 (UMLS CUI [2,3])
C0237442 (UMLS CUI [2,4])
C0021843 (UMLS CUI [3])
C0007570 (UMLS CUI [4])
C0205707 (UMLS CUI [5])
C0010674 (UMLS CUI [6])
Omeprazole | Prilosec | Antacids Effective Long-term
Item
5. ineligible to receive omeprazole (prilosec® otc) or other long-acting antacid
boolean
C0028978 (UMLS CUI [1])
C0700777 (UMLS CUI [2])
C0003138 (UMLS CUI [3,1])
C1280519 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
Able to swallow drug capsule
Item
6. inability to swallow study medication capsules
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
bortezomib | Additional Therapy Inappropriate
Item
7. not a suitable candidate in the opinion of the investigator for additional bortezomib therapy
boolean
C1176309 (UMLS CUI [1])
C1706712 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Illness Serious Preventing Informed Consent | Illness Preventing Therapeutic procedure Intensity | Mental disorder Serious Preventing Informed Consent | Mental disorder Preventing Therapeutic procedure Intensity
Item
8. other serious medical or psychiatric illness preventing informed consent or intensive treatment
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0522510 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C1292733 (UMLS CUI [3,3])
C0021430 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0522510 (UMLS CUI [4,4])
Comorbidity | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
9. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Pregnancy | Breast Feeding
Item
10. women who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection
Item
11. known history of hiv
boolean
C0019693 (UMLS CUI [1])
Malignant Neoplasms | Recurrent Malignant Neoplasm Evidence Absent | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
12. history of another prior cancer, except basal cell carcinoma or carcinoma in situ of the cervix (or if there has been no evidence of recurrence for at least 5 years)
boolean
C0006826 (UMLS CUI [1])
C1458156 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0007117 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
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