[c09aa8]: / templates / fillins / 582.txtFILLINS.csv

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# Blank 1 Frequency Blank 2 Frequency Blank 3 Frequency
1 1 27 on urine 6 for proteinuria > = 2 patients discovered to have > = 2 proteinuria on dipstick urinalysis at baseline shomcLd undergo a 24 hour urine collection and must demonstrate = < 1 g of protein in 24 hours to be eligible 3
2 3 urine dipstick for 4 present on 2 2 or greater and confirmed by a 24 hour urine collection > = 1 g / 24 hrs subjects may be re screened if proteinuria is shown to be controlled with or without intervention 2
3 12 participants having > = 1 3 at screening . subjects with a urine 2 2
4 18 patients with 3 as demonstrated by urine 2 or = < 1 gram / 24 hours 2
5 4 subject has 2 > = 1 on urine 2 urinalysis at baseline shomcLd undergo a 24 hour urine collection and must demonstrate < 1 g of protein in 24 hours 2
6 10 if there is 2 3 on 2 urinalysis at baseline shomcLd undergo a 24 hour urine collection and must demonstrate = < 1 g of protein in 24 hours 2
7 14 subjects having greater than 1 2 2 analysis shomcLd undergo a 24 hour urine collection and must demonstrate = < 1 g of protein in the 24 hour urine alternatively proteinuria testing can be performed according to local standards 2
8 37 urine for 2 = < 1 on 2 or routine urinalysis or a 24 hour urine collection for protein < 1000 mg of protein in 24 hours within 28 days prior to administration of study treatment 1
9 40 urine dipstick 2 < 2 patients discovered to have > = 2 proteinuria on 2 shows 2 protein 24 hour urinary protein shomcLd be done and be less than = < 2 grams / 24 hours 1
10 5 subjects having > = 1 1 shomcLd be < 2 patients discovered to have > = 2 proteinuria on 2 is > = 1 then a 24 hour urine for protein must demonstrate < 500 mg of protein in 24 hours to allow participation in the study 1
11 7 urine protein > = 2 patients discovered to have 1 1 with urinary protein is = < 1 on 1 testing will undergo 24 hours h urine collection for quantitative assessment of proteinuria subjects with urine protein > = 1 g / 24h will be ineligible 1
12 15 known 1 if urine 1 urinalysis at baseline must undergo a 24 hour urine collection for protein 1
13 26 a urine sample tested for 1 of = < less than 1 if urine 1 urinalysis at baseline shomcLd undergo a 24 hour urine collection and must demonstrate < 1 g of protein in 24 hour urine 1
14 34 urine protein creatinine ratio upc of = < 1 or less than or equal to 2 1 defined by the national cancer institute common terminology criteria for adverse events nci ctcae version v 4 . 0 grade > = 1 at baseline as measured by a urine 1 at baseline shomcLd undergo a 24 hour urine which must be an adequate collection and must demonstrate < 2 g of protein / 24 hour hr to allow participation in the study 1
15 42 within 28 days prior to administration of therapy 1 > = 2 . 0 g of protein in a 24 hour urine collection all patients with 2 protein on 1 patients must have a 24 hour urine collection patients are excluded if they have > = 500 mg protein on 24 hour urine collection 1
16 43 absence of 1 on 1 protein 2 at screening shomcLd undergo a 24 hour urine collection and must demonstrate 1g of protein in 24 hours to be eligible 1
17 46 patients with urine dipstick for 1 at baseline subjects unexpectedly found to have > = 2 proteinuria on a urine 1 testing will undergo 24 hour urine collection for quantitative assessment of proteinuria . participants with urine protein 1 gram / 24 hours will be ineligible . 1
18 49 patients must not have baseline 1 defined by the national cancer institute common terminology criteria for adverse events nci ctcae v 4 . 0 grade > = 1 at baseline as measured by a urine 1 or > = 1 . 0 g of protein in a 24 hour urine collection all patients with > = 2 protein on dipstick urinalysis at baseline must undergo a 24 hour urine collection for protein 1
19 55 patient has 1 defined by > = 2 protein by urinalysis ua or > = 1 gram protein by 24 hour urine collection note subjects that are > = 2 or greater on 1 testing will undergo a 24 hour urine collection for quantitative assessment of proteinuria . subjects with a urine protein > = 1 g / 24 hours will be ineligible . 1
20 57 urine protein urine protein creatinine upc ratio 1 . 0 or urine dipstick for 1 patients are allowed to have 0 trace or 1 protein by urine 1 but < 1 g protein on 24 hour urine are eligible to participate 1
21 2 NA as demonstrated by > = 1 . 5 gram of protein in a 24 hour urine collection all patients with > = 2 protein on 1 testing will undergo 24 hour urine collection for quantitative assessment of proteinuria . subjects with urine protein > = 1 g / 24 hour will be ineligible . 1
22 6 NA at screening as demonstrated by urinalysis with proteinuria 2 patients discovered to have 2 proteinuria on 1 or urinalysis to enroll 1
23 8 NA by the 1 or urine protein creatinine upc ratio > = 1 at screening if > = 1 proteinuria is detected on surveillance a 24 hour collection must be performed if eligibility is desired patients with a 24 hour urine protein content of = < 500 mg are eligible 1
24 9 NA as demonstrated by a urine protein creatinine upc ratio > = 1 . 0 at screening or urine 1 protein 2 at screening will undergo a 24 hour urine collection and must demonstrate 1g of protein in 24 hours to be eligible . 1
25 11 NA = < 2 by urinalysis or urine 1 patients are excluded if they have > = 500 mg protein on 24 hour urine collection 1
26 13 NA within 14 days of registration as demonstrated by either urine protein creatinine upc ratio > = 1 . 0 at screening or urine 1 testing will undergo 24 hour urine collection for quantitative assessment of proteinuria . participants with urine protein 1 grams g / 24 hours will be ineligible . 1
27 16 NA on two consecutive dipsticks taken no less than 1 week apart upc is the preferred test patients with > = 2 proteinuria on 1 urinalysis at baseline must undergo 24 hour urine collection for protein 1
28 17 NA as demonstrated by r n urine protein creatinine upc ratio > = 1 . 0 at screening or r n urine 1 or > = 1 . 0 g of protein in a 24 hour urine collection 1
29 19 NA as demonstrated by r n urine protein creatinine upc ratio > = 1 . 0 at screening patients discovered to have a upc > = 1 shomcLd undergo a 24 hour urine collection and must demonstrate = < 1 g of protein in 24 hours to be eligible or r n urine 1 testing will undergo 24 hour urine collection for quantitative assessment of proteinuria . participants with urine protein 1 g / 24 h will be ineligible . 1
30 20 NA < 2 or urine protein / creatinine upc ratio = < 1 . 0 note patients discovered to have > = 2 proteinuria on 1 urinalysis at baseline shomcLd undergo a 24 hour urine collection and must demonstrate 1g of protein in 24 hours to be eligible . 1
31 21 NA < 1 on 1 method must indicate 0 1 protein if dipstick reading is > = 2 a 24 hour urine specimen must demonstrate < 1 . 0 g of protein per 24 hours 1
32 22 NA urine protein creatinine ratio upc of = < 1 or = < 2 proteinuria on two consecutive urinalysis / 1 analysis or > = 500 mg / 24 hours 1
33 23 NA at screening as demonstrated by one of the following r n urine protein / creatinine upc ratio < 1 . 0 at screening or r n urine 1 2 1
34 24 NA at screening as demonstrated by either r n urine protein creatinine upc ratio > = 1 . 0 at screening or r n urine 1 for proteinuria 2 patients discovered to have 2 proteinuria on dipstick urinalysis at baseline shomcLd undergo a 24 hour urine collection and must demonstrate = < 1 g of protein / 24 hours to be eligible 1
35 25 NA > = 2 patients with > = 2 proteinuria on baseline 1 > = 3 or > = 2 gm / 24 hours 1
36 27 NA within 14 days prior to registration as demonstrated by either r n urine protein creatinine upc ratio < 1 . 0 at screening or r n urine 1 must also have a 24 hour urine collection demonstrating = < 500 mg over 24 hours 1
37 28 NA < 3 by urinalysis or urine 1 shomcLd undergo a 24 hour urine collection and demonstrate = < 1g of protein in 24 hours 1
38 29 NA < 2 patients with < 2 proteinuria on baseline 1 for proteinuria > = 2 patients discovered to have > = 2 proteinuria on dipstick urinalysis may either undergo urine protein creatinine upc testing and may participate if ratio < 1 . 0 or shomcLd undergo a 24 hour urine collection and must demonstrate = < 1 g of protein in 24 hours to be eligible 1
39 30 NA < 2 or urine protein / creatinine upc ratio = < 1 . 0 obtained = < 14 days prior to randomization r n note patients discovered to have > = 2 proteinuria on 1 testing if 2 seen on first test retest > = 24 hours later 1
40 31 NA as defined as > = 2 on urine 1 tests taken no less than 1 week apart patients with 2 proteinuria on dipstick must also have a upc of = < 0 . 5 on 2 consecutive samples 1
41 32 NA at screening as demonstrated by urine 1 for proteinuria < 2 patients discovered to have > = 2 proteinuria on dipstick urinalysis at baseline shomcLd undergo a 24 hour urine collection and must demonstrate = < 1 g of protein in 24 hours to be eligible 1
42 33 NA as demonstrated by urine protein creatinine ratio 1 . 0 at screening or urine 1 for proteinuria > = 2 patients discovered to have > = 2 proteinuria on dipstick urinalysis at baseline must have a upc ratio done that is < 1 . 0 to be eligible if the upc ratio is > = 1 . 0 then the patient shomcLd undergo a 24 hour urine collection which must demonstrate = < 1 g of protein in 24 hours for the patient to be eligible 1
43 35 NA urine 1 or 300 mg / dl on urine analysis or > = 500 mg / dl / 24 hours 1
44 36 NA > = 1 on 1 urinalysis at baseline shomcLd undergo a 24 hour urine collection and must demonstrate = < 1g of protein in 24 hours to be eligible 1
45 38 NA NA for proteinuria = < 2 note patients discovered to have > = 2 proteinuria on dipstick urinalysis at baseline shomcLd undergo a 24 hour urine collection and must demonstrate = < 1 g of protein in 24 hours to be eligible 1
46 39 NA NA if dipstick urinalysis shows > = 2 proteinuria 24 hour urine for protein must be < 2 grams 1
47 41 NA NA > = 2 1
48 44 NA NA for proteinuria 2 patients discovered to have 2 proteinuria on dipstick at baseline shomcLd undergo a 24 hour urine collection and must demonstrate < 2 g of protein in 24 hours to be eligible . 1
49 45 NA NA testing or 30 mg / dl 1
50 47 NA NA urinalysis patients with > = 1 proteinuria on dipstick urinalysis will undergo 24 hour urine collection for quantitative assessment note patients with > = 1 g / 24 hours will be ineligible 1