[c09aa8]: / clusters / 9knumclustersv2 / clust_2447.txt

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Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v]) resulting from prior therapy must be =< grade
Nervous system disorders (Common Terminology Criteria for Adverse Events version [CTCAE v]) resulting from prior therapy must be =< grade
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version .) resulting from prior therapy must be =< grade , with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
Patients with active >= Common Terminology Criteria for Adverse Events (CTCAE) version (v.) grade neuropathy are ineligible
Absolute neutrophil count (ANC) >= ,/mm^ , equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events [CTCAE] version [v] .) grade
Patients may have received prior surgery; all adverse events associated with prior surgery must have resolved to =< grade (per Common Terminology Criteria for Adverse Events [CTCAE] .) prior to registration
Absolute neutrophil count (ANC) greater than or equal to ,/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] ) resulting from prior therapy must be =< grade
Nervous system disorders (by Common Terminology Criteria for Adverse Events version . [CTCAE V .]) resulting from prior therapy must be =< grade , with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
Patient has Common Toxicity Criteria for Adverse Effects (CTCAE) v . grade ? hemorrhage
Clinically active infection as judged by the site investigator (>= grade by Common Terminology Criteria for Adverse Events [CTCAE] version [v] )
History of high grade (Common Terminology Criteria for Adverse Events [CTCAE] >= grade ) immune mediated adverse event from prior cancer immunotherapy
Thyroid function abnormality ? Common Toxicity Criteria for Adverse Effects (CTCAE) Grade .
Any toxicity due to prior therapy that has not been resolved to less than Grade severity by Common Terminology Criteria for Adverse Events (CTCAE, Version . or higher) criteria
For subjects with muscle invasive disease: not suitable neoadjuvant cisplatinbased chemotherapy as determined by the following:\r\n* Creatinine clearance less than ml/min\r\n* Common Terminology Criteria for Adverse Events (CTCAE) grade (gr) >= hearing loss\r\n* CTCAE gr >= neuropathy
Have any reported baseline lab values with a grade or toxicity as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version .
Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= Common Toxicity Criteria [CTC] grade [Common Terminology Criteria for Adverse Events (CTCAE) version .])
Recovery from acute toxicity of prior treatment for RCC (to =< grade the active version of Common Terminology Criteria for Adverse Events [CTCAE] or to a level permitted under other sections of inclusion/exclusion criteria)
Subjects must have progressed despite at least prior line of treatment for metastatic and/or unresectable urothelial cancer. However, cisplatin-ineligible (defined by a calculated creatinine clearance of >= but < mL/min OR Common Terminology Criteria for Adverse Events [CTCAE] version [v] grade >= audiometric hearing loss OR CTCAE v grade >= peripheral neuropathy OR ECOG performance status [PS] = ), chemotherapy-naive subjects are also eligible
Proteinuria < Common Terminology Criteria for Adverse Events (CTCAE) grade or greater
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade
Ineligible to receive cisplatin by meeting one or more of the following criteria\r\n* Creatinine clearance of < mL/min\r\n* Hearing loss of dB at two contiguous frequencies\r\n* Common Terminology Criteria for Adverse Events (CTCAE) version (v) grade or higher peripheral neuropathy\r\n* New York Heart Association class III or IV heart failure\r\n* ECOG performance status or higher
Serum sodium, potassium, and calcium levels equivalent to grade adverse event (AE) values as defined by Common Terminology Criteria for Adverse Events (CTCAE) version .
Resolved acute effects of any prior therapy to baseline severity or grade =< Common Terminology Criteria for Adverse Events (CTCAE) version (v.) . except for adverse events (AEs) not constituting a safety risk by investigator judgment
Absolute neutrophil count ? , cells/uL equivalent to Common Terminology Criteria for Adverse Events version . (CTCAE v.) grade
Platelets ? ,/uL equivalent to Common Terminology Criteria for Adverse Events version . (CTCAE v.) grade
Any immunotherapy-related adverse events Common Terminology Criteria for Adverse Events (CTCAE) > grade at the time of registration
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade
Common Terminology Criteria for Adverse Events (CTCAE) version (v). grade - neuropathy
Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade or greater
Bilirubin =< . times upper limit of normal (Common Terminology Criteria for Adverse Events [CTCAE] grade baseline)
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
Preexisting grade or nervous system disorder as per Common Terminology Criteria for Adverse Events (CTCAE) version .
Unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade due to prior therapies
Symptomatic nodal disease, i.e. scrotal, penile or leg edema (>= Common Terminology Criteria for Adverse Events [CTCAE] grade )
Absolute neutrophil count (ANC) greater than or equal to ,/uL, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) version (v) grade
Patients must have been treated with fulvestrant for at least days as their most current anti-cancer treatment, and they must be tolerating fulvestrant with at most grade I toxicity by Common Terminology Criteria for Adverse Events (CTCAE) v.
Hepatic toxicity grade (using Common Terminology Criteria for Adverse Events [CTCAE] version standard definitions)
Baseline hearing deficit (Common Terminology Criteria for Adverse Events [CTCAE] version . grade or higher)
Patients with unresolved diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
Participants with active diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) grade despite medical management
Common Terminology Criteria for Adverse Events (CTCAE) v Grade ? audiometric hearing loss
Active, ongoing toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade or higher) from prior therapy
History of Common Terminology Criteria for Adverse Events (CTCAE) grade >= hypersensitivity to paclitaxel or Cremophor EL
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [V] .) resulting from prior therapy must be =< grade
Participants with diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) grade
Grade - electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] ):
Active, clinically serious infections > Common Terminology Criteria for Adverse Events (CTCAE) grade
Cholesterol < Common Terminology Criteria for Adverse Events (CTCAE) grade
Recovery from previous cancer treatment (=< grade by Common Terminology Criteria for Adverse Events [CTCAE] . criteria) prior to first radiation treatment
Documented hypercoagulable disorders or vasculopathies:\r\n* International normalized ratio (INR) value more than a grade toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v) . criteria (> -. x upper limit of normal [ULN]; > -. times above baseline if on anticoagulation)\r\n* Activated partial thromboplastin time (APTT) value more than a grade toxicity by CTCAE v . criteria (> ULN-. x ULN)
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade anxiety
Any valve disease Common Terminology Criteria for Adverse Events (CTCAE) grade
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) (version .) grade
Previous intolerance to BCG intravesical therapy suggested by development of systemic BCG infection in the past and/or grade or greater adverse effect by Common Terminology Criteria for Adverse Events (CTCAE) version (v) .
Have recovered from prior drug-related toxicity to grade =< Common Terminology Criteria for Adverse Events version (CTCAE v. ), within days of initiation of on-study treatment
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade
Active clinically serious infection > Common Toxicity Criteria for Adverse Events (CTCAE version . [v .]) grade
Absolute neutrophil count (ANC) greater than or equal to ,/mm^, equivalent to Common Toxicity Criteria for Adverse Events version (v). (CTCAE) grade
Subject has cardiac disorders (Common Terminology Criteria for Adverse Events [CTCAE] version . Grade or ).
Patient must have a corrected QT (QTc) interval on electrocardiogram (ECG) =< . seconds by Bazetts calculation (=< Common Terminology Criteria for Adverse Events [CTCAE] version [v.] grade ) prior to randomization
Bilirubin greater than . x upper limit of normal (ULN) (Common Terminology Criteria for Adverse Events [CTCAE] v. grade )
Active Common Terminology Criteria for Adverse Events (CTCAE) version . grade or higher viral, bacterial, or fungal infection
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade
CTCAE (Common Terminology Criteria for Adverse Events) Grade ? bleeding disorder within weeks before the start of anetumab ravtansine
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) version (v), grade not controlled with antibiotics
History of grade (Common Terminology Criteria for Adverse Events [CTCAE] version [v] ) or greater acute intracranial hemorrhage
Patient with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade ; (CTCAE version .)
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade anxiety
No proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade or greater
Significant neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) version (ver.) . or current version (grade and above, or grade with pain) within days prior to enrollment
The participant has uncontrolled hypertension, as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version ., prior to initiating study treatment, despite antihypertensive intervention.
Electrocardiography (EKG) corrected QT (QTc) < msec (Common Terminology Criteria for Adverse Events [CTCAE] grade )
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade anxiety
? Common Terminology Criteria for Adverse Events (CTCAE) Grade thrombocytopenia, OR
Participants with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
Persistent Common Toxicity Criteria for Adverse Effects (CTCAE v.) greater than or equal to grade diarrhea regardless of etiology.
Adequate pulmonary function, defined as ? Common Terminology Criteria for Adverse Events (CTCAE) Grade dyspnea and saturated oxygen (SaO) ? % on room air
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade or systemic infection requiring IV antibiotic therapy within days preceding the first dose of study drug
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade or systemic infection requiring IV antibiotic therapy within days preceding the first dose of study drug
Unresolved diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) version , grade
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] ) resulting from prior therapy must be < grade
Have a grade or greater laboratory abnormalities (Common Terminology Criteria for Adverse Events version [CTCAE v]) at baseline for any of the following:\r\n* Hemoglobin\r\n* White blood cell count\r\n* Platelet count\r\n* Alanine transferase\r\n* Aspartate transferase\r\n* Creatinine
Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade >= (Common Terminology Criteria for Adverse Events [CTCAE] version [v] .)
Patients with active diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE version ) grade at the time of signing consent
Patients with known grade or higher (per Common Terminology Criteria for Adverse Events [CTCAE] version . [v..] criteria) active systemic or cutaneous viral, bacterial, or fungal infection
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
Patients must have completed surgical resection and adjuvant chemotherapy (adjuvant radiotherapy excluded) with no significant persisting treatment related toxicity (grade toxicity per Common Terminology Criteria for Adverse Events [CTCAE] version [v]. allowed) as determined by the treating physician
History of severe (Common Terminology Criteria for Adverse Events [CTCAE] version [v] . grade or higher) allergic reaction to a drug, vaccination, or biological preparation
Ongoing or active infection of Common Terminology Criteria for Adverse Events (CTCAE) Grade ?
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade
Absolute neutrophil count (ANC) greater than or equal to ,/ul, equivalent to Common Toxicity Criteria (Common Toxicity Criteria for Adverse Events [CTCAE] version [v.].) grade
Pts who have grade III-IV elevations in liver transaminases (as defined by the Common Terminology Criteria for Adverse Events [CTCAE] version [v.] .) or a bilirubin in excess of . mg/dl
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade
RECURRENT/ PROGRESSIVE DIPG (STRATUM ): Patients have diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
Absolute neutrophil count (ANC) >= ,/mcl, equivalent to Common Terminology Criteria (CTCAE version [v] .) grade
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade
Anxiety ? Common Terminology Criteria (CTC) of adverse events (AE) grade .
Clinically significant non-hematologic toxicity after prior therapy has recovered to grade per Common Terminology Criteria for Adverse Events (CTCAE) version . or newer
Resolution of all transplant-related toxicity to =< grade per Common Terminology Criteria for Adverse Events (CTCAE) version (v.)
Active, clinically serious infections defined as ?Grade according to NCI Common Toxicity Criteria for Adverse Effects (CTCAE), version .
toxicity attributed to previous anticancer therapy that did not resolve to Common Terminology Criteria for Adverse Events (CTCAE) grade =
Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than from previous anti-EGFR therapy at time of randomization
Proteinuria by Common Terminology Criteria for Adverse Events (CTCAE) grade or greater
Active infections of CTCAE (Common Terminology Criteria for Adverse Events Version .) Grade > or infections of CTCAE Grade not responding to therapy
Documented hypersensitivity (Common Terminology Criteria for Adverse Events [CTCAE] grade >= ) to any drug containing polysorbate
Grade or worse edema within days to study day , per Common Terminology Criteria for Adverse Events (CTCAE) version (v)
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade
Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade or higher.
Presence of peripheral edema > Grade (Common Terminology Criteria for Adverse Events [CTCAE] version )
Patients with diarrhea > Common Terminology Criteria for Adverse Events Version (CTCAE V.) grade
Presence of neuropathy > grade (Common Terminology Criteria for Adverse Events [CTCAE] version .) at baseline
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade anxiety
Newly diagnosed clinical grade or higher radiation pneumonitis according to Common Terminology Criteria for Adverse Events (CTCAE) version . criteria
Diarrhea < grade by Common Terminology Criteria for Adverse Events (CTCAE) version
Common Terminology Criteria for Adverse Events (CTCAE) grade or higher proteinuria
Depression >= grade (Common Terminology Criteria for Adverse Events [CTCAE] version [v] .)
Hepatic or renal toxicity (glomerular filtration rate [GFR] < ) greater than or equal to grade (using Common Terminology Criteria for Adverse Events [CTCAE] version standard definitions)
Have grade or symptomatic dry mouth (xerostomia) according to CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE version .)
Reporting grade or greater of the following symptoms persistently for more than weeks: neuropathic pain, allodynia, areflexia, dysesthesia, paresthesia, hyperesthesia, hypoesthesia or glove and stocking syndrome as defined by Common Terminology Criteria for Adverse Events (CTCAE version [v.] .)
Potassium, < . mmol/L despite supplementation; or above the Common Terminology Criteria for Adverse Events (CTCAE) grade upper limit
No clinically relevant deviations in renal function (serum creatinine > grade Common Terminology Criteria for Adverse Events [CTCAE] version .); maximal interval between confirmation of renal function and injection of F FSPG is week
CLINICAL SYMPTOMS (EACH AT LEAST GRADE BY COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS [CTCAE] DEFINITIONS)
Participants must not have residual adverse events from previous therapy greater than Common Terminology Criteria for Adverse Events version . (CTCAE v.) grade at the time of registration