--- a +++ b/clusters/9knumclustersv2/clust_1482.txt @@ -0,0 +1,98 @@ +Platelets >= ,/mm^, equivalent to CTCAE v . grade - +Bilirubin =< . x ULN (CTCAE v . grade ) +Recovered to ? grade NCI CTCAE version . from toxicity of prior chemotherapy or biologic therapy administered more than weeks earlier. +Ongoing adverse effects from prior systemic treatment > NCI CTCAE Grade (with the exception of Grade alopecia) +Presence of ? CTCAE grade toxicity (except alopecia and ototoxicity, which are excluded if ? CTCAE grade ) due to prior cancer therapy. +Ongoing infection > grade NCI-CTCAE v. +Persistent proteinuria >= grade NCI-CTCAE v. +Any Grade > (according to the NCI CTCAE .) adverse reaction unresolved from previous treatments and not readily managed and controlled with supportive care. +Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade or as per the NCI-CTCAE v .. +Non-manageable electrolyte imbalances including hypokalemia, hypocalcemia, or hypomagnesemia (Grade or greater based on NCI-CTCAE v .). +Ongoing, clinically significant bleeding (CTCAE grade or ) +Significant recent bleeding history defined as NCI CTCAE grade ? within the last months, unless precipitated by an inciting event (e.g., surgery, trauma, injury) +Ongoing infection > grade NCI-CTCAE v. +Ongoing infection > grade NCI-CTCAE version (v) . +Patients cannot have experienced a significant (CTCAE Grade or with or without neutropenia) infection within weeks of their first dose of MT-. +Serum bilirubin less than or equal to . x ULN (CTCAE v. grade ) +Subject has symptomatic cardiac disorders (CTCAE v. . Grade and ) +Afebrile (<C per CTCAE v.); +Patient has not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery is defined as ? NCI-CTCAE Grade , except for liver function test levels which must be <Grade . +Afebrile (<C per CTCAE v.); +(Bevacizumab-related exclusion) Any previous venous thromboembolism > NCI CTCAE grade +serum potassium NCI-CTCAE version . Grade <; +serum calcium NCI-CTCAE version . Grade <; +serum magnesium NCI-CTCAE version . Grade <; +Ongoing infection > grade NCI-CTCAE v. +Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade >= (CTCAE version [v].) +Patients with hypertriglyceridemia defined as > mg/dL (CTCAE Grade ). +Serum creatinine =< . X ULN (CTCAE grade baseline) +Patients who have active clinically serious infection > CTCAE grade are not eligible +Serum creatinine =< . x ULN (CTCAE grade baseline) +Patients exhibiting baseline grade or by CTCAE criteria are excluded +Ongoing infection > Grade NCI-CTCAE v . +Creatinine less than . x ULN (CTCAE Grade ) +Bilirubin less than . x ULN (CTCAE Grade ) +Bilirubin less than or equal to . x ULN (CTCAE v grade ) +Serious uncontrolled infection > grade (CTCAE v.) +Serious uncontrolled infection > grade (CTCAE v.) +At least one clinical symptom probably or definitely attributed to KSHV-MCD\r\n* Intermittent or persistent fever for at least week (> Celsius degree [C])\r\n* Fatigue (Common Terminology Criteria for Adverse Events [CTCAE] grade or greater)\r\n* Gastrointestinal symptoms (includes nausea and anorexia) (CTCAE grade or greater)\r\n* Respiratory symptoms (includes cough and airway hyperreactivity) (CTCAE grade or greater) +Clinical relevant AEs or laboratory results related to previous anti-neoplastic therapy have not resolved to a NCI-CTCAE grade ?. +Ongoing infection > grade NCI-CTCAE v. +Recovery to baseline or ? Grade CTCAE ver.. +AST =< grade +Patients with ataxia >= CTCAE grade are ineligible +Grade - electrolyte abnormalities (CTCAE, v. ): +Triglycerides < CTCAE grade +Magnesium >= within institutional normal limits, or =< grade according to NCI-CTCAE version . if judged clinically not significant by the investigator +Subjects who have an active clinically serious infection of CTCAE grade >= +Bilirubin less than or equal to . x ULN (CTEP CTCAE version ., grade ) +Subject has any other organ dysfunction (CTCAE version . Grade ) that will interfere with the administration of the therapy according to this protocol. +Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade +Serum creatinine ? . X ULN (CTCAE Grade baseline) +Ongoing clinical adverse events NCI CTCAE Grade > resulting from prior cancer therapies +Evidence of significant CNS haemorrhage i.e. CTCAE grade or above; +All AEs resulting from prior chemotherapy, surgery, or radiotherapy, must have resolved to at least NCI-CTCAE (v. .) Grade (except for laboratory parameters outlined below). +Ongoing infection > grade NCI-CTCAE v . +Ongoing infection > Grade NCI-CTCAE v.. +Subjects with known Gilbert's syndrome who have serum bilirubin ? x ULN (NCI CTCAE v. Grade ) may be enrolled. +Ongoing infection > grade NCI-CTCAE v. +? CTCAE Grade anemia, OR +? CTCAE Grade hematoma (bleed) +Active infection > CTCAE Grade , that is considered clinically serious by the treating physician +Any Grade or toxicities (according to NCI CTCAE) resolved for at least weeks prior to first treatment +CTCAE v. grade or anorexia or nausea related to metastatic disease. +Clinically significant bleeding NCI-CTCAE version . Grade or higher within days before randomization. +Bilirubin =< . x ULN, CTCAE grade +EXPANSION COHORT ONLY: Resolution of any pre-existing toxicity from prior therapy to NCI CTCAE version . =< grade except neuropathy (=< grade ) and tinnitus (=< grade ), and hearing loss (=< grade ) +Any toxicity from prior chemotherapy has resolved or Grade (NCI-CTCAE, Version .) +Ongoing infection > Grade NCI-CTCAE v.. +Subject has an ongoing toxicity ? Grade (NCI CTCAE Version .) attributable to prior medication to treat solid tumor (except alopecia) at screening. +Active, clinically serious infections of NCI CTCAE v. Grade or higher within weeks prior to Cycle , Day +Subject has an ongoing toxicity greater than or equal to grade (NCI CTCAE version .) attributable to prior NSCLC treatment at the time of screening. +Bilirubin less than or equal to . x ULN (CTCAE v. grade ) +Ongoing infection > grade NCI-CTCAE v. +Anxiety ? CTCAE grade +Patients with active clinically serious infections defined as >= grade according to NCI CTCAE, version . +Subjects with valvular heart disease CTCAE (version .) grade +? CTCAE Grade anxiety. +Diarrhoea CTCAE v. Grade ? +Evidence of uncontrolled bradycardia or other cardiac arrhythmia defined as ?Grade according to NCI CTCAE, version ., or uncontrolled hypertension +History of bronchopulmonary hemorrhage NCI CTCAE >/= Grade within months prior to randomization +NCI CTCAE (version .) Grade or higher toxicities due to prior therapy that have not shown improvement and are considered to interfere with current study medication +Active clinically serious infections defined as >= Grade according to NCI CTCAE +CTCAE Grade or fatigue. +Any >=Grade hypophosphatemia (per CTCAE v.) at the time of enrolment +Active clinically serious infection > NCI-CTCAE grade +? CTCAE grade anxiety +Active clinically serious infection > CTCAE v . grade +Active clinically serious infections > Grade (NCI-CTCAE Version .) +Ongoing infection > CTCAE grade +Baseline alopecia (defined CTCAE v. grade > ) +Ongoing infection > grade NCI-CTCAE v. +History of persistent proteinuria >= grade NCI-CTCAE v. +AST > . x ULN (CTCAE grade ) +Bilirubin > . x ULN (CTCAE grade ) +Current alopecia grade or greater as per NCI-CTCAE v.., or significant hair loss or hair breakage +Hepatic toxicity >= grade (using CTCAE version standard definitions) +Not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade <= or baseline. +For Adjuvant Treatment: All AEs resulting from surgery must have resolved to NCI-CTCAE (v. .) Grade ?