[c09aa8]: / clusters / final9knumclusters / clust_1243.txt

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Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v]4) resulting from prior therapy must be =< grade 2
Nervous system disorders (Common Terminology Criteria for Adverse Events version 4 [CTCAE v4]) resulting from prior therapy must be =< grade 2
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) resulting from prior therapy must be =< grade 2, 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.) 4 grade 2 neuropathy are ineligible
Absolute neutrophil count (ANC) >= 1,500/mm^3 , equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 3.0) grade 1
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4) resulting from prior therapy must be =< grade 2
Nervous system disorders (by Common Terminology Criteria for Adverse Events version 5.0 [CTCAE V 5.0]) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
Clinically active infection as judged by the site investigator (>= grade 2 by Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4)
History of high grade (Common Terminology Criteria for Adverse Events [CTCAE] >= grade 3) immune mediated adverse event from prior cancer immunotherapy
Any toxicity due to prior therapy that has not been resolved to less than Grade 2 severity by Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03 or higher) criteria
Have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= Common Toxicity Criteria [CTC] grade 2 [Common Terminology Criteria for Adverse Events (CTCAE) version 4.0])
Recovery from acute toxicity of prior treatment for RCC (to =< grade 1 the active version of Common Terminology Criteria for Adverse Events [CTCAE] or to a level permitted under other sections of inclusion/exclusion criteria)
Proteinuria < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Absolute neutrophil count ? 1,500 cells/uL equivalent to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03) grade 1
Platelets ? 100,000/uL equivalent to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03) grade 1
Any immunotherapy-related adverse events Common Terminology Criteria for Adverse Events (CTCAE) > grade 1 at the time of registration
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 3-4 neuropathy
Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
Bilirubin =< 1.5 times upper limit of normal (Common Terminology Criteria for Adverse Events [CTCAE] grade 1 baseline)
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Preexisting grade 3 or 4 nervous system disorder as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Persistence of any clinically relevant (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or above) toxicities from previous AML therapy
Unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 due to prior therapies
Symptomatic nodal disease, i.e. scrotal, penile or leg edema (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 3)
Absolute neutrophil count (ANC) greater than or equal to 1,500/uL, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade 1
Hepatic toxicity grade 2 (using Common Terminology Criteria for Adverse Events [CTCAE] version 4 standard definitions)
Baseline hearing deficit (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0 grade 2 or higher)
Patients with unresolved diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
History of infection meeting any of the following criteria:\r\n* Any infection that would be scored as grade 4 by Common Terminology Criteria for Adverse Events (CTCAE) that occurred within six weeks of study screening\r\n* Any infection that would be scored as grade 3 by CTCAE that occurred within two weeks of study screening\r\n* History of fungal and mycobacterial infections, unless at least six weeks has passed since the completion of induction antimicrobial therapy; patients may be receiving consolidation therapy for infections of these types
Participants with active diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 despite medical management
Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade ?2 audiometric hearing loss
Active, ongoing toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or higher) from prior therapy
History of Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 hypersensitivity to paclitaxel or Cremophor EL
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [V] 4.0) resulting from prior therapy must be =< grade 2
Participants with diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4):
Active, clinically serious infections > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Cholesterol < Common Terminology Criteria for Adverse Events (CTCAE) grade 3
Recovery from previous cancer treatment (=< grade 1 by Common Terminology Criteria for Adverse Events [CTCAE] 4.0 criteria) prior to first radiation treatment
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
Any valve disease Common Terminology Criteria for Adverse Events (CTCAE) grade
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03) grade 2
Have recovered from prior drug-related toxicity to grade =< 1 Common Terminology Criteria for Adverse Events version 4 (CTCAE v. 4), within 21 days of initiation of on-study treatment
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Active clinically serious infection > Common Toxicity Criteria for Adverse Events (CTCAE version 4.0 [v 4.0]) grade 2
Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to Common Toxicity Criteria for Adverse Events version (v)3.0 (CTCAE) grade 1
Subject has cardiac disorders (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 Grade 3 or 4).
Patient must have a corrected QT (QTc) interval on electrocardiogram (ECG) =< 0.48 seconds by Bazett’s calculation (=< Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4 grade 2) prior to randomization
Bilirubin greater than 1.5 x upper limit of normal (ULN) (Common Terminology Criteria for Adverse Events [CTCAE] v4.0 grade 1)
None of the following co-morbid conditions:\r\n* Cataracts of grade 2 or greater as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0\r\n* Retinopathy of grade 2 or greater as per CTCAE version 4.0\r\n** Note: patients that have cataracts that do not require surgery are eligible\r\n** Note: serious adverse events will be reported on CTEP-Adverse Event Reporting System (AERS) using CTCAE version (v)5.0\r\n* Deep vein thrombosis/pulmonary embolism (DVT/PE) within the past 6 months\r\n** Note: patients that are on anticoagulant therapy for maintenance are eligible as long as the DVT and/or PE occurred > 6 months prior to enrollment, and there is no evidence for active thrombosis (either DVT or PE)
Active Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 3 or higher viral, bacterial, or fungal infection
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
CTCAE (Common Terminology Criteria for Adverse Events) Grade ?2 bleeding disorder within 4 weeks before the start of anetumab ravtansine
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) version (v)4, grade 2 not controlled with antibiotics
History of grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4) or greater acute intracranial hemorrhage
Patient with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2; (CTCAE version 4.0)
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
No proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
Significant neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) version (ver.) 4.03 or current version (grade 3 and above, or grade 2 with pain) within 14 days prior to enrollment
The participant has uncontrolled hypertension, as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, prior to initiating study treatment, despite antihypertensive intervention.
Electrocardiography (EKG) corrected QT (QTc) < 480 msec (Common Terminology Criteria for Adverse Events [CTCAE] grade 2)
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
? Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 thrombocytopenia, OR
Participants with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Adequate pulmonary function, defined as ? Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ? 92% on room air
Unresolved diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) version 4, grade 1
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4) resulting from prior therapy must be < grade 2
Have a grade 2 or greater laboratory abnormalities (Common Terminology Criteria for Adverse Events version 4 [CTCAE v4]) 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 >= 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0)
Any unresolved chronic toxicities > grade 2, measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v4)
Patients with active diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE version 4) grade 2 at the time of signing consent
Patients with known grade 3 or higher (per Common Terminology Criteria for Adverse Events [CTCAE] version 4.0 [v.4.0] criteria) active systemic or cutaneous viral, bacterial, or fungal infection
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
History of severe (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03 grade 3 or higher) allergic reaction to a drug, vaccination, or biological preparation
Ongoing or active infection of Common Terminology Criteria for Adverse Events (CTCAE) Grade ? 3
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (Common Toxicity Criteria for Adverse Events [CTCAE] version [v.]4.0) grade 1
Pts who have grade III-IV elevations in liver transaminases (as defined by the Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 4.0) or a bilirubin in excess of 1.5 mg/dl
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Absolute neutrophil count (ANC) >= 1,500/mcl, equivalent to Common Terminology Criteria (CTCAE version [v] 4.03) grade 1
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Anxiety ? Common Terminology Criteria (CTC) of adverse events (AE) grade 3.
Clinically significant non-hematologic toxicity after prior therapy has recovered to grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or newer
Resolution of all transplant-related toxicity to =< grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4
toxicity attributed to previous anticancer therapy that did not resolve to Common Terminology Criteria for Adverse Events (CTCAE) grade =1
Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
Proteinuria by Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
Active infections of CTCAE (Common Terminology Criteria for Adverse Events Version 4.03) Grade >2 or infections of CTCAE Grade 2 not responding to therapy
Documented hypersensitivity (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) to any drug containing polysorbate 80
Grade 2 or worse edema within 14 days to study day 1, per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher.
Presence of peripheral edema > Grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4)
Patients with diarrhea > Common Terminology Criteria for Adverse Events Version 4 (CTCAE V.4) grade 2
Presence of neuropathy > grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) at baseline
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
Newly diagnosed clinical grade 2 or higher radiation pneumonitis according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
Diarrhea < grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4
Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher proteinuria
Depression >= grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0)
Hepatic or renal toxicity (glomerular filtration rate [GFR] < 30) greater than or equal to grade 2 (using Common Terminology Criteria for Adverse Events [CTCAE] version 4 standard definitions)
Have grade 1 or 2 symptomatic dry mouth (xerostomia) according to CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Reporting grade 1 or greater of the following symptoms persistently for more than 2 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.] 4.03)
Potassium, < 4.0 mmol/L despite supplementation; or above the Common Terminology Criteria for Adverse Events (CTCAE) grade 1 upper limit
No clinically relevant deviations in renal function (serum creatinine > grade 2 Common Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week
CLINICAL SYMPTOMS (EACH AT LEAST GRADE 1 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 4.0 (CTCAE v4.0) grade 2 at the time of registration