[c09aa8]: / clusters / 9knumclustersv2 / clust_2145.txt

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Resolution of all acute AEs resulting from prior cancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events version . (NCI CTCAE v.) grade ? or to that patient's pre-study baseline (except alopecia or neuropathy)
Any pre-existing medical condition that would represent toxicity in excess of grade as measured by CTCAE (National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events version .) unless the symptom is not considered medically significant by the treating investigator (e.g., alopecia)
Patients must not have any unresolved toxicity greater than National Cancer Institute (NCI)-CTCAE version (v) . grade from previous anti-cancer therapy except alopecia within days prior to registration
Recovered from all toxicities associated with prior treatment, to acceptable baseline status or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version , grade of or , except for toxicities not considered a safety risk, such as alopecia or vitiligo
Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicities see below limits for inclusion) or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version ., Grade of or , except for toxicities not considered a safety risk (eg, alopecia or vitiligo).
Clinically significant toxicity (other than alopecia) from prior therapy that has not resolved to Grade less than or equal to (</=) (according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version .) prior to Day of Cycle
National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v. grade or higher toxicities due to any prior therapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia, that has not resolved to ?Grade , as determined by National Cancer Institute Common Toxicity Criteria for Adverse Effects (CTCAE) v . (http://evs.nci.nih.gov/ftp/CTCAE/About.html).
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version . (NCI CTCAE v. .) grade or higher from previous anti-cancer therapy, except alopecia, at the time of randomization
At least weeks must have elapsed since the end of prior chemotherapy, biological agents ( weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . grade =< (or tolerable grade ) or back to baseline (except for alopecia or neuropathy); any number of prior therapies for recurrent/metastatic ACC are allowed, with the exception of previous treatment with PD- pathway inhibitors
Inadequate recovery from toxicity attributed to prior anti-cancer therapy.\r\n* With the exception of alopecia, fatigue, or peripheral neuropathy, patients must have recovered to =< grade (National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version [v] .) residual toxicity prior to first dose of protocol-indicated treatment.
Toxicities of prior therapy (except alopecia) should be resolved to =< grade as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.; patients with long-standing stable grade neuropathy or others (e.g., adrenal insufficiency or hypothyroidism on stable doses of replacement therapy) may be allowed after discussion with the study principal investigator (PI)
Not recovered from adverse events (AE)s or toxicities due to previous treatments to a grade or less specified in National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version . excepting, albumin (< . g/dL), AST and ALT in patients with liver metastases (> x ULN) alkaline phosphatase (ALP) in patients with bone metastases (> x ULN) and alopecia
Patients may have received any number of prior lines of therapy. All prior systemic anti-cancer treatment-related toxicities must be less than or equal to grade according to the Common Terminology Criteria for Adverse Events version (CTCAE version .; National Cancer Institute [NCI], ) at the time of enrollment. This does not include alopecia and grade or less peripheral neuropathy.
Prior treatment toxicities have not resolved to =< grade according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . (except for alopecia and neuropathy)
Presence of toxicities attributed to prior therapy other than alopecia that have not resolved to grade (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version ) or baseline before administration of study drug
Presence of any toxicities attributed to prior anti-cancer therapy, other than alopecia, that have not resolved to grade (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]) or baseline before administration of study drug
Not recovered to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) . grade =< from adverse events (AEs) (except alopecia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug
Toxicities of prior therapy (except alopecia) should be resolved to =< grade as per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v).; patients with long-standing stable grade neuropathy may be considered after discussion with the study principal investigator (PI)
Presence of ? CTCAE grade toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version .)
Lack of recovery of prior adverse events to grade =< severity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v] .) (except alopecia) due to therapy administered prior to the initiation of study drug dosing; stable persistent grade peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the investigator
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version . <=Grade at the time of enrollment (except for alopecia).
Recovery from toxicity from any prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events version . (CTCAE v.) to grade or better (except for =< grade neuropathy, alopecia, xerostomia, dysphagia, or mucositis)
Patients with ongoing toxicities > grade according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version . (excluding alopecia) due to prior anti-cancer therapy
All prior treatment-related toxicities must be National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v =< Grade (except alopecia [permissible at any Grade] and peripheral neuropathy [which must be =< Grade ]) at the time of treatment allocation.
Prior treatment toxicities not resolved to =< grade according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . except alopecia and neuropathy
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (version .) grade or higher toxicities due to any prior therapy (e.g. radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
Subject has unresolved toxicities from prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (National Cancer Institute [NCI] CTCAE version [v] .) grade or higher clinically significant toxicity (excluding alopecia)
Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE); patients with long-standing stable grade neuropathy may be considered after discussion with the overall principal investigator (PI), but may not receive carboplatin and paclitaxel as the reference regimen, if randomized to that arm
Prior non-hematologic treatment toxicities must be resolved to =< grade according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version ., with the exception of the following grade toxicities: alopecia; dry skin; spleen disorders, hearing impairment; tinnitus; hypothyroidism; hyperthyroidism; endocrine disorders; blurred vision; cataracts; constipation; gastroesophageal reflux; fatigue; abnormal coagulation tests international normalized ratio (INR) and/or activated partial thromboplastin time (aPTT); weight gain or weight loss; anorexia; glucose intolerance; hypoalbuminemia; hypokalemia; muscle weakness; dysgeusia; paresthesias; peripheral motor and/or sensory neuropathy; hot flashes; hypertension
All prior anti-cancer treatment-related toxicities must be less than or equal to grade according to the Common Terminology Criteria for Adverse Events version (CTCAE version .; National Cancer Institute [NCI], ) at the time of enrollment; a notable exception are endocrinopathies caused by immune checkpoint inhibitors that are appropriately treated with medical management (e.g. hormone replacement therapy, anti-diabetic agents)
The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . (v.) grade =< from adverse events (AEs) (except alopecia, anemia, and lymphopenia) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study
Patients with grade toxicities or less using the Common Toxicity Criteria (version .) developed by the National Cancer Institute of the United States of America (USA) (Common Terminology Criteria for Adverse Events version .) related to cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam
Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version . (CTCAE v..) Grade attributed to any prior therapy/procedure excluding alopecia, anemia and/or hypothyroidism
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version ., must be <=Grade at the time of enrolment except for alopecia and Grade peripheral neuropathy.
All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version ., ) must be <= Grade at the time of enrollment, except for alopecia and Grade neuropathy.
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version . (NCI CTCAE v .) grade or higher from previous anti-cancer therapy, except alopecia
Any > grade (according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.].) adverse reaction unresolved from previous treatments or not readily managed and controlled with supportive care; the presence of alopecia of any grade and peripheral neuropathy ? grade without pain is allowed
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version . (NCI CTCAE v.) grade or higher from previous anti-cancer therapy, except alopecia, at the time of randomization
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version . (NCI CTCAE v.) grade or higher from previous anti-cancer therapy, except alopecia; in specific cases, will be allowed with permission from the principal investigator
Have side effects (except alopecia) of prior treatment resolved to at least Grade according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCICTCAE) (Version .)
Any non-hematologic toxicity (excluding alopecia) from prior treatment that has not resolved to Grade less than or equal to (<=) (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version .) at screening
At least days since the end of prior systemic VEGF-targeted treatment (ie, sunitinib, pazopanib, axitinib, or sorafenib), radiotherapy, or surgical procedure with resolution of all treatment-related toxicity (except alopecia and hypothyroidism) either to Grade or (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version .) or to baseline.
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v). grade or with the exception of alopecia and laboratory values listed per the inclusion criteria
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version . <=Grade at the time of enrollment (except for alopecia).
National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version .) Grade or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia)
Prior treatment toxicities must be resolved to =< grade according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version .
Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see below limits for inclusion) or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version ., Grade of or , except for toxicities not considered a safety risk (e.g., alopecia or vitiligo).
Prior treatment toxicities have not resolved to =< grade according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . (except clinically insignificant toxicities such as alopecia)
At least weeks must have elapsed since the end of prior systemic treatment ( weeks for bevacizumab-containing regimens) or radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . grade =< (or tolerable grade ) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism); any number of prior therapies for recurrent/metastatic ACC are allowed
All prior treatment- related toxicities must be National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. <=Grade (except alopecia [permissible at any Grade] and peripheral neuropathy [which must be <= Grade ]) at the time of treatment allocation.
The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) . grade =< from adverse events (AEs) (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug
At least weeks must have elapsed since the end of prior systemic treatment ( weeks for bevacizumab- containing regimens) or radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . grade =< (or tolerable grade ) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism); any number of prior therapies for recurrent/metastatic ACC are allowed
Has not recovered (recovery is defined as National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE version (v).] grade =< ) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting the inclusion requirements stated in the inclusion criterion
Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) (version ) grade of =< ; chemotherapy induced alopecia and grade peripheral neuropathy are allowed
Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version ) grade of =< ; chemotherapy induced alopecia and grade peripheral neuropathy are allowed
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version . (NCI CTCAE v.) grade or higher from previous anti-cancer therapy, except alopecia
Subjects who have not recovered from toxicities as a result of prior anticancer therapy to less than Grade severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v., except alopecia and infertility.
Resolution of chemotherapy and radiation therapy related toxicities to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version . Grade or lower severity, except for diarrhea (which must be Grade without a supportive antidiarrheal medications) and alopecia (any grade)
Prior anti-cancer treatment related toxicities except alopecia and lab values as outlined above must be =< grade as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)
Has recovered from all acute National Cancer Institute (NCI) Common Toxicity Criteria grade II-IV acute non-hematologic toxicities from prior therapy per the judgment of the principal investigator (PI)
Any unresolved toxicity greater than Grade , except for alopecia, (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version .) from parent study treatment at the time of transition to this study.
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version . (NCI CTCAE v.) Grade or higher from previous anti-cancer therapy, except alopecia;
E . Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.) at the time of randomization.
Any unresolved toxicity > Grade (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version .) from parent study treatment, except for alopecia, will need to be approved by the GSK Medical Monitor
At least weeks must have elapsed since the end of prior systemic treatment and/or weeks since completion of radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version . grade =< (or tolerable grade ) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism) prior to starting study drug treatment; any number of prior therapies for recurrent/metastatic salivary gland cancer are allowed
Toxicities of prior therapy (except alopecia) should be resolved to less than or equal to grade as per National Cancer Institute Common Terminology Criteria for Adverse Events version . (NCI-CTCAE v.); patients with long-standing stable grade neuropathy may be considered after discussion with the overall principal investigator (PI)
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version . <=Grade at the time of enrollment (except for alopecia)
Has persistent grade > clinically significant toxicities related to prior antineoplastic therapies (except for alopecia). Stable sensory neuropathy ? grade National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version . is accepted
Lack of recovery of prior adverse events to Grade ? severity (National Cancer Institute Common Terminology Criteria for Adverse Events version ) (except alopecia) due to therapy administered prior to the initiation of study drug dosing.
Unresolved toxicity greater than Grade National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version from previous anti-cancer therapy, with the exception of alopecia and peripheral neuropathy. Lymphoma subjects with <= Grade lymphopenia can be enrolled at the discretion of the investigator.
Prior treatment toxicities must be resolved to =< grade according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version .
Patients must have recovered from toxicity related to prior therapy (chemotherapy, surgery or radiation) to grade =< (defined by Common Terminology Criteria for Adverse Events [CTCAE]); the National Cancer Institute (NCI) CTCAE version will be used for toxicity and adverse event reporting
Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ? ) from the acute toxicities of previous therapy, except treatment related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
Has recovered from all acute National Cancer Institute (NCI) Common Toxicity Criteria grade II-IV non-hematologic toxicities from prior therapy per the judgment of the principal investigator (PI)
Acute toxicities from any prior treatment, surgery, or radiotherapy must be National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version . Grade less than or equal to (<=)
Subject must have recovered from the effects of prior systemic antineoplastic or radiation therapy(s) to ? Grade (National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version .) severity or to subject's baseline values, excluding alopecia.
Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >(National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v.) at the time of randomization.
Prior treatment toxicities (i.e. any toxicity from treatment of a previous cancer ) must be resolved to =< grade according to National Cancer Institute (NCI) CTCAE version . (except alopecia)
Any acute toxicities due to prior anti-cancer treatments and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade of =< (except alopecia)
Recovery from all reversible AEs of previous medical therapies to baseline or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade , except for alopecia (any grade)
Adverse events (with exception of alopecia, peripheral sensory neuropathy and those listed in specific exclusion criteria) from any prior anti cancer therapy of grade > (National Cancer Institute Common Terminology Criteria [NCI CTCAE] version [v.].)
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version . (CTCAE v.) Grade or higher from previous anti-cancer therapy, except alopecia
The subject has not recovered from toxicity due to prior therapy to Baseline level or National Cancer Institute Common Terminology Criteria for Adverse Events Version . (NCI CTCAE v.) Grade or less (except alopecia). Residual chemotherapy-induced neuropathy grade less than equal to (<=) is permitted.
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version . (NCI CTCAE version .) Grade or higher from previous anti-cancer therapy, except alopecia.
Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosourea, mitomycin-C, targeted therapy and radiation) =< weeks prior to starting study drug, or who have side effects (except alopecia, lymphopenia and hyperglycemia) that have not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade or less
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version . (NCI CTCAE v.) Grade or higher from previous anti-cancer therapy, except alopecia.
Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. Grade or higher from previous anti-cancer therapy, including major surgery except those that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profile of dabrafenib (e.g., alopecia and/or peripheral neuropathy related to platinum or vinca alkaloid based chemotherapy).
Adequate recovery from prior therapy, all side effects (except alopecia) have resolved to Grade or less according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCI-CTCAE) Version .
Unresolved toxicity greater than National Cancer Institute-Common Terminology Criteria for Adverse Events version Grade from previous anti-cancer therapy except alopecia.
Prior chemotherapy and/or radiation are allowed; at least weeks must have elapsed since prior large-field radiation therapy; patients must have been off previous anti-cancer therapy for at least weeks ( weeks for mitomycin-C and nitrosoureas); and recovered from all treatment related toxicity to =< grade according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . (with the exception of alopecia and radiation-induced taste changes); prior temozolomide treatment is not restricted
All acute toxicities as a result of any prior treatment must have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v). grade or less at the time of signing the Informed Consent Form (ICF) (Note: ongoing grade neuropathy as a result of treatment with a cytotoxic chemotherapy regimen is permitted)
Toxicities of prior therapy (excepting alopecia and sensory neuropathy) should be resolved to < grade per the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version ; all appropriate treatment areas should have access to a copy of the CTCAE version
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events, version ) must be <=Grade at the time of enrollment except for alopecia, and grade neuropathy.
Complete recovery to baseline or Grade per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . from adverse effects of prior surgery, radiotherapy, endocrine therapy, and other therapy, as applicable, with the exception of Grade alopecia from prior chemotherapy
Acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version .) grade of =< ; chemotherapy-induced alopecia and grade peripheral neuropathy are allowed