Proteinuria
Has proteinuria
Persistent proteinuria >= grade 3 NCI-CTCAE v4.0
Proteinuria greater than 2 grams/24 hours.
Proteinuria < 1 g/day
Proteinuria value > 1.0 g at screening
Significant proteinuria at baseline (> 500 mg/ 24 h, or > 2+ on spot analysis)
Proteinuria >3.5 gm/24 hr
Proteinuria >1+ on urinalysis or >1 gm/24hr.
Within 7-10 days of study drug administration: Urinalysis no greater than 1+ hematuria or proteinuria
No history of medical condition resulting in nephrotic range proteinuria.
Proteinuria >1+ on urinalysis or >1 gm/24hr.
Proteinuria, grade 2 (i.e., >= 2+ proteinuria)
Absence of proteinuria
Proteinuria < grade 2
Proteinuria > 100 mg/dl on urine analysis
Proteinuria > 1gram/24 hrs
Subject has proteinuria > 3.5 gm over 24 hrs are not eligible for the study
< 1+ proteinuria
No hematuria and/or proteinuria greater than 1+ on urinalysis
Urinalysis; abnormalities on urinalysis (i.e. proteinuria) will not exclude patients from participation on study
Patients who have proteinuria CTCAE version (v)4.03 grade 2 or greater within < 30 days of registration
Grade >= 2 proteinuria at screening (or known prior)
=< grade 2 hematuria (criteria applicable only for dose levels that include isotretinoin) and =< grade 2 proteinuria
Grade 2 or higher proteinuria and hematuria
Proteinuria (>= 2 g/24 hours)
Urinalysis with < 2+ proteinuria
Significant proteinuria at baseline (>= 500 mg/24 hours [h])
Proteinuria < trace
Urinalysis with no greater than 1+ hematuria or proteinuria
Proteinuria level =< 2+
Proteinuria CTCAE grade 2 or greater
Persistent proteinuria of Common Toxicity Criteria (CTC) grade 3 or higher (>= 3.5 g/24 hours [hrs])
Proteinuria less than or equal to 1+ proteinuria on two consecutive dipsticks taken no less than week apart, or a urine protein:creatinine (UPC) ration of =< 1
Patients with history of proteinuria grade >= 2
Proteinuria at screening as demonstrated by urinalysis with proteinuria ? 2+.
Persistent proteinuria of CTCAE grade 3 (>3.5g/24 hours)
Urinalysis with < grade 1 proteinuria
>= grade 1 proteinuria at baseline or clinically significant impairment of renal function
Subject has proteinuria > 3.5 gm over 24 hrs. are not eligible for the study
Grade 3/4 proteinuria
Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart
Proteinuria > 500 mg/24hrs
Proteinuria CTCAE grade 2 or greater
Patient’s with a history of kidney disease or persistent proteinuria must have < grade 3 proteinuria per NCI CTCAE v4.0 at screening; if a patient has a history of kidney disease or persistent proteinuria, a urine protein test will be performed on a random urine sample; if the result is normal then no additional testing is required; if the result is abnormal, a 24 hour urine will be collected to determine if proteinuria is < grade 3
Patient’s with a history of kidney disease or persistent proteinuria must have < grade 3 proteinuria per NCI CTCAE v4.0 at screening; if a patient has a history of kidney disease or persistent proteinuria, a urine protein test will be performed on a random urine sample; if the result is normal then no additional testing is required; if the result is abnormal, a 24 hour urine will be collected to determine if proteinuria is < grade 3
Patient’s with a history of kidney disease or persistent proteinuria must have < grade 3 proteinuria per NCI CTCAE v 4.0 at screening; if a patient has a history of kidney disease or persistent proteinuria, a urine protein test will be performed on a random urine sample; if the result is normal then no additional testing is required; if the result is abnormal, a 24 hour urine will be collected to determine if proteinuria is < grade 3
Patients with 2+ proteinuria/moderate or more at baseline are ineligible
Patient must not have known proteinuria >= 500mg/24 hours
Greater than 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart or 24-hour urine protein of > 1 g; patients with < 2+ proteinuria are eligible following initial determination by urinalysis within 1 week prior to enrollment and do not need the urinalysis repeated
>= grade 2 proteinuria
History of persistent proteinuria >= grade 3 NCI-CTCAE v4.0
Persistent proteinuria >= grade 3 NCI-CTCAE v4.0 (> 3.5 g/24 hours [hrs], measured by urine protein:creatinine ratio on a random urine sample)
Persistent proteinuria >= grade 3 NCI-CTCAE v4.0 (> 3.5 g/24 hrs, measured by urine protein:creatinine ratio on a random urine sample)
FOR ALL PHASES (Ib AND II): Proteinuria of >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 as estimated by urine protein : creatinine ratio > 3.5 on a random urine sample
Persistent proteinuria >= grade 3 per NCI-CTCAE v4.0 (> 3.5 g/24 hours [hrs], measured by urine protein: creatinine ratio on a random urine sample)
Persistent proteinuria >= grade 3 NCI-CTCAE version (v) 4.0 (> 3.5 g/24 hours [hrs], measured by urine protein: creatinine ratio on a random urine sample)
Proteinuria of CTCAE grade 3 or higher (> 3.5 g/24 h, measured by urine protein: creatinine ratio on a random urine sample)
REGORAFENIB EXCLUSION CRITERIA: Persistent proteinuria >= grade 3 (> 3.5 g/24 hours [hrs], measured by urine protein:creatinine ratio on a random urine sample)
Proteinuria =< grade 1 (ie, =< 1+ [30 mg/dL] using a random urine sample or < 1.0 gm using a 24-hour sample)\r\n* Note: if urine sample indicates >= grade 2 proteinuria (ie, 2+ [100 mg/dL]), a 24-hour urine sample must be collected and tested; urine protein in the 24-hour sample must be < 1.0 gm/24 hours
Persistent proteinuria >= grade 3 NCI-CTCAE v4.0 (> 3.5 g/24 hrs, measured by urine protein:creatinine ratio on a random urine sample)
Proteinuria =< 2+ (100 mg/dL) using a random urine sample or < 3.0 gm using a 24-hour sample; Note: If urine sample indicates >= 2+ [100 mg/dL]), a 24-hour urine sample must be collected and tested; urine protein in the 24-hour sample must be < 3.0 gm/24 hours
Proteinuria of CTCAE grade 3 or higher (estimated by urine protein: creatinine ratio >= 3.5 on a random urine sample); patients who recently (i.e., at least 30 days prior to registration) discontinued an anti-angiogenic therapy which caused proteinuria (ie, grade 2 (> 2 to > 3 g of protein or 1-3.5 g/24 hours [h]) or grade 3 proteinuria (> 4 of protein or > 3.5 g/24 h) are not eligible for enrollment until proteinuria improves to < 2 g of protein per 24 h
Proteinuria >= grade 3 (> 3.5 g/24 hours, measured by urine protein: creatinine ratio on a random urine sample)
Persistent proteinuria ? Grade 3 NCI-CTCAE v4.03 (> 3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample).
Persistent proteinuria >= grade 3 NCI-CTCAE v4.0 (> 3.5 g/24 hrs, measured by urine protein:creatinine ratio on a random urine sample)
Persistent proteinuria grade 2 or higher measured by urine protein:creatinine ratio on a urine sample or during 24-hour assessment
Persistent proteinuria >= grade 3 NCI-CTCAE v4.0 (> 3.5 g/24 hours [hrs], measured by urine protein:creatinine ratio on a random urine sample)
Persistent proteinuria ? Grade 3 NCI CTCAE v4.0 as defined as > 3.5 g/24 hours, measured by urine protein: creatinine ratio on a random urine sample.
Persistent proteinuria >= grade 3 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 (> 3.5 g/24 hours [hrs], measured by urine protein: creatinine ratio on a random urine sample)