[c09aa8]: / templates / fillins / 591.txtFILLINS.csv

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# Blank 1 Frequency Blank 2 Frequency
1 1 patients who are on treatment with drugs known to prolong the qt / qtc interval 3 22
2 3 use of drugs that comcLd prolong the qt interval within 7 days before the start of study therapy 1 5 x mcLn r n serum amylase = < 1 . 5 x mcLn 1
3 4 any medications that are known to prolong the qtc interval 1 g . within 5 half lives or 7 days prior to starting study drug 1
4 5 use of a drug known to prolong the cardiac qt interval 1 11 . 3 . 1
5 6 unable or unwilling to discontinue concomitant use of drugs that are known to prolong the qt interval 1 g . tricyclics azithromycin 1
6 7 concomitant use of medication s with a known risk to prolong the qt interval and / or known to cause torsades de pointe that cannot be discontinued within 5 half lives or 7 days prior to starting study drug or replaced by safe alternative medication 1 avoid concomitant administration of agents that prolong the qt interval except at the discretion of the investigator . if advised patients shomcLd discontinue the use of these agents at least 2 weeks before the study begins . no uncontrolled arrhythmias . 1
7 8 ponatinib r n female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from randomization through 4 months after the end of treatment r n discontinuation of any medications known to contribute significantly to the risk of qt prolongation at least 48 hours prior to start of study drug levaquin and zofran are an exception of note certain agents that prolong the corrected qt interval qtc may be allowed but only after discussion with the chemotherapy pharmacist shomcLd the investigator believe that therapy with a potentially qt prolonging medication is vital to an individual subject s care then additional electrocardiograms ecgs shomcLd be done at the investigator s discretion to ensure the subject s safety r n serum lipase = < 1 1 g . azoles 1
8 10 the use of concomitant medications that prolong the qt / qtc interval 1 are permitted but caution is advised and patients shomcLd be closely monitored 1
9 11 patients taking medications that are known to prolong the qt interval unless they can be transferred to other medications within 5 half lives prior to dosing or unless the medications can be properly monitored during the study 1 NA
10 12 patient requires the use of concomitant medications that are contraindicated with cardiac glycosides and / or are known to prolong the qt / qtc interval during study participation see appendix 2 1 NA
11 13 concomitant medication s with a known risk to prolong the qt interval and / or known to cause torsades de pointe that cannot be discontinued or replaced by safe alternative medication e 1 NA
12 14 subjects taking medications that are known to prolong the qt interval see section 9 1 NA
13 15 subjects taking medications that are known to prolong the qt interval unless they can be transferred to other medications within 5 half lives prior to dosing 1 NA
14 16 congenital long qt syndrome or subjects taking concomitant medications known to prolong the qt interval e 1 NA
15 17 methadone 1 NA
16 18 subject is taking medication known to prolong the qt interval 1 NA
17 19 patients taking medications known to prolong the qtc interval directly or that interact pharmacodynamically with medicines to prolong the qtc interval 1 NA
18 20 patients with a mean qtc interval greater than 480ms are excluded 1 NA
19 21 human immunodeficiency virus hiv cirrhosis uncontrolled hypothyroidism or cardiac failure r n concomitant medications known to prolong the qt interval during the same time as pasireotide is to be administered unless approved by principal investigator pi and qtc < 470 standard transplant medications that are known to prolong the qt e 1 NA
20 22 ondansetron etc 1 NA
21 23 participant s current disease state must be one for which there is no known curative therapy 1 NA
22 24 patient s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life 1 NA
23 25 current disease state must be one for which there is currently no known curative therapy or no additional therapies proven to prolong survival with an acceptable quality of life 1 NA
24 26 therapeutic options participant s current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life 1 NA
25 27 pre registration patients with relapsed or refractory solid tumors and without known curative therapy or therapy proven to proven to prolong survival with acceptable quality of life 1 NA
26 28 must have a disease that is relapsed / refractory to all potentially curative standard treatment regimens or must have a current disease for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life 1 NA
27 29 current disease state must be one for which there is currently no known curative therapy 1 NA