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 |