[c09aa8]: / clusters / 9knumclustersv2 / clust_2601.txt

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Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day , history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio [INR] =< . and partial thromboplastin time [PTT] within . x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subjects safety, or obtaining informed consent; therapeutic level dosing of warfarin can be used with close monitoring of prothrombin time (PT)/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency
Concurrent use of warfarin
Patients taking warfarin are not eligible; patients on therapeutic doses of anticoagulants are excluded from study
Requires the use of warfarin (because of potential drug-drug interactions that may potentially increase the exposure of warfarin)
Warfarin use, even if low dose warfarin is not acceptable; however, other anti-coagulants (e.g. aspirin, enoxaparin and heparin derivatives, thrombin inhibitors, etc) are acceptable
Use of full dose, therapeutic anti-coagulation with warfarin
Requires therapeutic anticoagulation with warfarin at baseline\r\n* Patients must be off warfarin or warfarin-derivative anti-coagulants for at least days prior to starting study drug, however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed
Current use of anticoagulants (warfarin, heparin, direct thrombin inhibitors) at therapeutic levels.
For patients requiring anti-coagulation with vitamin K antagonists, therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site. Exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR. Consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate. If clinically indicated, prophylactic low dose warfarin may be given to maintain central catheter patency.
Patients requiring the use of warfarin are excluded
Concurrent use of warfarin
Patients receiving therapeutic doses of warfarin
Requires the use of warfarin (because of potential drug-drug interactions that may potentially increase the exposure of warfarin)
Requires concomitant therapeutic anticoagulation (i.e., warfarin) for reasons other than venous catheter patency
Concurrent use of warfarin
Concomitant treatment with therapeutic anticoagulants such as warfarin
Current use of anticoagulants (warfarin, heparin, direct thrombin inhibitors) at therapeutic levels
Therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency
Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within months before randomization/enrollment
Concomitant use of warfarin and HMG-CoA reductase inhibitors (statins)
Therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency
Therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency
Current use of anticoagulants (warfarin, heparin, direct thrombin inhibitors) at therapeutic levels
Requires therapeutic anticoagulation with warfarin at baseline; patients must be off warfarin or warfarin-derivative anti-coagulants for at least days prior to starting study drug; however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed
Requires the use of warfarin, marcumar, or phenprocoumon
Warfarin use is provisionally allowed
Current use of therapeutic anticoagulants such as warfarin or heparin
Thrombolytics or treatment doses of warfarin within days of initiating treatment; patients who require low dose warfarin for central venous catheter patency are allowed to enter if their dose is < mg per day total AND their international normalized ratio (INR) is =< .
Current use of a prohibitive medication(s) as listed in Section .. NOTE: Use of anticoagulants such as warfarin is permitted; however, the international normalization ratio (INR) must be monitored in accordance with local institutional practice.
Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
Concurrent use of therapeutic warfarin is allowed. However, anticoagulants that do not have reversal agents available are prohibited.
Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to mg orally [PO] daily for thromboembolic prophylaxis is allowed)
Use of warfarin, metronidazole or ornidazole for therapeutic use
Currently receiving treatment with therapeutic doses of warfarin sodium.
Concurrent use of therapeutic warfarin
Concurrent use of therapeutic warfarin
Patients receiving therapeutic doses of warfarin
Requires the use of warfarin
Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic INR monitoring
Patients on anticoagulant therapy with unstable dose of warfarin and/or having an out-of- therapeutic range INR (> ) within the weeks prior to study entry
Requires therapeutic anticoagulation with warfarin at baseline; patients must be off warfarin or warfarin-derivative anti-coagulants for at least days prior to starting study drug; however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed.
Concurrent use of therapeutic warfarin
Concurrent use of therapeutic warfarin
Current use of therapeutic warfarin.
Current use of warfarin or other anticoagulants
Use of Warfarin
Current use of American ginseng, ramelteon, or warfarin
Use of antibiotics, antiplatelets (e.g. clopidogrel), or anticoagulants (e.g. warfarin) within the last months
No use of full dose, therapeutic anti-coagulation; however, low dose warfarin for catheter prophylaxis or acetylsalicylic acid are acceptable
The patient requires therapeutic doses of any anticoagulant, including LMWH. Concomitant use of warfarin, even at prophylactic doses, is prohibited.