Eligibility Toxicity NCT00531076

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StudyEvent: Eligibility
1. Eligibility Toxicity NCT00531076

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

ID.1

Item

1. cytologically or histologically confirmed stages ii or iii non-squamous nsclc

boolean

C0007131 (UMLS CUI [1,1])
C2585890 (UMLS CUI [1,2])

ID.2

Item

2. no evidence of tumour invading major blood vessels and no active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to randomization.

boolean

C0019079 (UMLS CUI [1,1])
C1272790 (UMLS CUI [1,2])

ID.3

Item

3. no prior systemic therapy for nsclc. prior surgery and/or extra-thoracic irradiation is permitted.

boolean

C1515119 (UMLS CUI [1])

ID.4

Item

4. presence of at least one measurable target lesion

boolean

C2986546 (UMLS CUI [1])

ID.5

Item

5. age 18 or greater.

boolean

C0001779 (UMLS CUI [1])

ID.6

Item

6. who performance status of 0 or 1.

boolean

C1298650 (UMLS CUI [1])

ID.7

Item

7. acceptable pulmonary function as defined by a fev1 of ≥30% and a dlco of ≥40% of predicted

boolean

C0231921 (UMLS CUI [1])

ID.8

Item

8. life expectancy of at least 12 weeks.

boolean

C0023671 (UMLS CUI [1])

ID.9

Item

9. adequate hematological, renal and hepatic functions

boolean

C0232741 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])

ID.10

Item

absolute neutrophil count >2x109/l.

boolean

C0948762 (UMLS CUI [1])

ID.11

Item

platelet count > 100x109/l.

boolean

C0032181 (UMLS CUI [1])

ID.12

Item

total bilirubin < 1.5 x unl

boolean

C0005437 (UMLS CUI [1])

ID.13

Item

asat/alat < 2 x unl

boolean

C0004002 (UMLS CUI [1,1])
C0001899 (UMLS CUI [1,2])

ID.14

Item

alkaline phosphatase < 5 x unl

boolean

C0002059 (UMLS CUI [1])

ID.15

Item

creatinine < 130 μmol/l

boolean

C0010294 (UMLS CUI [1])

ID.16

Item

creatinine clearance > 60 ml/min; measured or calculated

boolean

C0373595 (UMLS CUI [1])

ID.17

Item

10. urine dipstick for proteinuria < 1+. if urine dipstick is ≥ 1, 24 hour urine must demonstrate < 500 mg of protein in 24 hours.

boolean

C0033687 (UMLS CUI [1])

ID.18

Item

11. no pre-existing sensory neurotoxicity grade 2 (ctc)

boolean

C0235032 (UMLS CUI [1])

ID.19

Item

12. no active (uncontrolled) infection requiring antibiotics

boolean

C3714514 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

ID.20

Item

1. mixed tumor types with small cell lung cancer or squamous cell carcinoma

boolean

C1368354 (UMLS CUI [1])

ID.21

Item

2. other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension

boolean

C0012634 (UMLS CUI [1])

ID.22

Item

3. serious non-healing wound or ulcer.

boolean

C0750433 (UMLS CUI [1,1])
C0041582 (UMLS CUI [1,2])

ID.23

Item

4. asat and alat > 1,5 x unl

boolean

C0004002 (UMLS CUI [1,1])
C0001899 (UMLS CUI [1,2])

ID.24

Item

5. alkaline phosphatase 5 x unl

boolean

C0002059 (UMLS CUI [1])

ID.25

Item

6. evidence of bleeding diathesis or coagulopathy.

boolean

C0005779 (UMLS CUI [1])

ID.26

Item

7. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.

boolean

C1321605 (UMLS CUI [1])

ID.27

Item

8. participation in other trial with investigational drug or treatment modality.

boolean

C0013230 (UMLS CUI [1])

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Eligibility Toxicity NCT00531076