--- a
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+No current peripheral neuropathy > grade 2 at time of randomization
+Grade 2 or greater peripheral neuropathy
+Peripheral neuropathy Grade ? 2
+Peripheral neuropathy of any etiology that exceeds grade 1
+Ongoing sensory or motor neuropathy Grade ?2.
+Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
+Patients must not have baseline peripheral neuropathy that exceeds grade 1
+No grade >= 2 peripheral motor or sensory neuropathy
+Grade >= 2 neuropathy
+=< grade 2 peripheral neuropathy; patients with grade 1 peripheral neuropathy with pain will be excluded
+Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1
+No grade 2 or higher neuropathy
+=< grade 2 peripheral neuropathy
+RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): =< grade 2 peripheral neuropathy
+>= Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)
+Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
+Presence of grade > 2 peripheral neuropathy or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
+If applicable, patient with >= grade 2 peripheral neuropathy within 14 days before enrollment
+Peripheral neuropathy >= 2
+Grade >= 2 peripheral neuropathy
+Patients with grade 2 or higher peripheral neuropathy will be excluded in the dose escalation phase of the protocol
+Patients with a baseline peripheral neuropathy >= grade 2 will not be eligible
+Patients must have < grade 2 neuropathy (sensory/motor) within 7 days prior to registration
+Patients with preexisting grade II peripheral neuropathy
+ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients must not have grade 3 or higher peripheral neuropathy
+ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients must not have grade 3 or higher peripheral neuropathy
+Baseline neuropathy of > grade 2
+Peripheral neuropathy ? Grade 2.
+Patients with peripheral neuropathy of grade 2 or higher
+Grade >= 2 peripheral neuropathy at the present time
+Peripheral neuropathy of Grade 2 within 3 weeks prior to the first study therapy
+Subject has preexisting sensory or motor neuropathy Grade ? 2 at baseline
+SAFETY RUN-IN: Patients with baseline grade 2 neuropathy
+Peripheral neuropathy ?grade 3.
+>= grade 3 neuropathy at the time of enrollment
+Grade 2 or greater peripheral neuropathy
+Peripheral neuropathy >= grade 2 at screening
+Subjects with pre-existing grade II peripheral neuropathy
+All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to grade less than or equal to (<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
+Peripheral neuropathy > Grade 2 despite supportive therapy.
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Patients who have >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period are not eligible
+Participants with grade >= 3 peripheral motor or sensory neuropathy
+G>1 pre-existing peripheral neuropathy
+Peripheral neuropathy of severity greater than grade 1
+Grade 2 or higher peripheral neuropathy at screening
+Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior cycle 1, day 1
+Neuropathy > grade 1
+Neuropathy (sensory and motor) less than or equal to CTCAE v4.0, grade 1
+Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
+Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
+Patients who have pre-existing motor or sensory neuropathy of a severity ? grade 1 by CTCAE v4.0 criteria
+Peripheral neuropathy greater than or equal to Grade 2
+Participants with >= grade 2 peripheral neuropathy
+Clinically significant peripheral neuropathy at the time of study entry. Patients with pre-existing peripheral neuropathy will be allowed to receive single agent DKN-01
+Pre-existing peripheral neuropathy Grade 2 or higher
+Baseline peripheral neuropathy of severity > grade 1
+Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy) ? Grade 2, per the CTCAE v4.0.
+Grade ? 3 sensory or motor neuropathy.
+Patient has ? grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Presence of >= grade 2 peripheral neuropathy
+Baseline peripheral neuropathy >= grade 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
+Peripheral neuropathy >= grade 2
+Presence of peripheral neuropathy > grade 1
+Patients with > grade 2 sensory peripheral neuropathy.
+Peripheral neuropathy =< grade 1 at the time of registration
+Pre-existing neuropathy Grade 2 or higher
+Neurosensory neuropathy > grade 2 at baseline.
+Presence of > grade 1 peripheral neuropathy
+Neuropathy ? Grade 2.
+Grade 2 peripheral neuropathy or higher or grade 1 with pain on clinical examination during the screening period
+Peripheral neuropathy >Grade 2
+Patients must not have peripheral neuropathy ? grade 2
+Patient has >= grade 2 peripheral neuropathy or neuropathy with pain, regardless of grade that is seen on clinical examination during the screening period
+Patients with a history of grade >= 2 neuropathy
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Grade >= 2 peripheral neuropathy
+Peripheral neuropathy > grade 1
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade less than or equal to (<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
+Patients with greater than or equal to grade 2 peripheral neuropathy or active herpes infection
+Peripheral neuropathy > CTCAE grade 1
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Patients with >= grade 2 neuropathy
+Peripheral neuropathy >= grade 3 on clinical examination or grade 2 with pain during the screening period
+Significant neuropathy > grade 2 at the time of first dose or within 14 days of enrollment
+Neuropathy > grade 1
+< Grade 2 pre-existing peripheral neuropathy per CTCAE
+Peripheral neuropathy ? grade 3 on clinical examination or grade 2 with pain during the screening period
+Peripheral neuropathy > grade 2 or > grade 1 with pain on clinical examination during the screening period
+Clinically significant (>= grade 2) peripheral neuropathy at the time of study entry
+Patients with grade 2 or higher neuropathy
+All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to grade less than or equal to 1, except alopecia (any grade) and grade 2 peripheral neuropathy
+Patients must not have Grade 2 or higher peripheral neuropathy.
+Sensory or motor neuropathy ? grade 2
+Patients with pre-existing grade >= 3 peripheral neuropathy
+Patients with pre-existing peripheral neuropathy that would limit treatment with taxanes and platinum agents
+Preexisting sensory neuropathy Grade ? 2
+Preexisting motor neuropathy Grade ? 2
+Peripheral neuropathy grade > 1
+Peripheral neuropathy > grade 1, except for grade 2 without limitations on instrumental daily life activities;
+Neuropathy (sensory and motor) less than or equal to CTCAE v4.03 grade 1
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior to screening
+Exclude patients with pre-existing neuropathy grade 2 or higher
+Peripheral neuropathy >= grade 3 sensory neuropathy or >= grade 2 sensory neuropathy with pain within 14 days of registration; prior neuropathy of this severity improved due to medical management such as gabapentin are potentially eligible
+Patients with grade 2 or greater neuropathy
+Has greater than Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy graded according to the Modified (\Balis\) Pediatric Scale of Peripheral Neuropathies.
+Patients must have < grade 2 pre-existing peripheral neuropathy (per CTCAE)
+CTCAE grade >= 2 peripheral neuropathy is NOT permitted
+Sensory/peripheral neuropathy.
+Significant neuropathy (grades 3–4, or grade 2 with pain) within 21 days prior to registration
+Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
+Effects of any other prior therapies not reverted to ? Grade 1 (or ? Grade 2 for alopecia and peripheral neuropathy).
+Pre-existing peripheral neuropathy of grade II or higher
+Grade 3 peripheral neuropathy within 14 days before enrollment.
+Peripheral neuropathy Grade 1 with pain or Grade 2 or higher peripheral neuropathy of any cause on clinical examination during the Screening period.
+Pre-existing > grade 2 peripheral sensory neuropathy
+Active >= grade 3 peripheral neuropathy
+Pre-existing sensory neuropathy of grade >= 2
+Grade 2 or greater neuropathy
+Patients with any baseline grade 2 neuropathy
+Peripheral neuropathy > grade 1
+Patients with > grade 1 peripheral neuropathy
+Sensory or motor neuropathy >= grade 2
+Pre-existing grade 3 or 4 neuropathy
+Peripheral neuropathy grade 1 or less.
+Grade 3 baseline neuropathy
+Current Grade greater than (>) 1 peripheral neuropathy by clinical examination
+Grade 2 sensory or Grade 1 painful peripheral neuropathy
+Ongoing sensory or motor neuropathy Grade 2 or higher.
+Neuropathy: patients must have =< grade 1 neuropathy at enrollment
+No peripheral neuropathy
+Sensory or motor neuropathy >= Grade 2.
+Baseline grade II peripheral neuropathy
+Peripheral neuropathy >= grade 2 on clinical examination or grade 1 with pain during the screening period
+Current peripheral neuropathy >= grade 2
+Peripheral neuropathy >= grade 2 at screening
+Nervous system disorder (i.e., paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
+Patient has greater than or equal than grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
+Patient has >= grade 2 peripheral neuropathy on clinical examination during the screening period
+Peripheral neuropathy grade 2 or greater
+Patients with a peripheral neuropathy > grade 1
+Neuropathy =< grade 1 at the time of registration
+Diabetic neuropathy (any grade)
+Participants with baseline peripheral neuropathy greater than grade 2
+All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to grade =< 1, except alopecia (any grade) and < grade 2 peripheral neuropathy
+Neuropathy grade >1
+Pre-existing neuropathy greater than grade 1
+Peripheral neuropathy >= grade 2
+Baseline grade II peripheral neuropathy
+Grade 3 or higher peripheral neuropathy
+Patients with greater than or equal to grade 2 peripheral neuropathy at baseline
+Significant neuropathy (grades 2 or grade 1 with pain) within 14 days prior to enrollment
+Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
+Grade 2 or greater neuropathy
+No symptoms attributable to grade 2 or higher peripheral neuropathy
+Patients with grade 2 or higher peripheral neuropathy are excluded
+Neuropathy >= grade 1
+Patient has baseline neuropathy of >= grade 2
+Patients with a peripheral neuropathy > grade 1
+ENTRECTINIB EXCLUSION CRITERIA: Peripheral neuropathy >= grade 2
+Patient has >= grade 2 neuropathy, sensory, with or without pain, motor, or autonomic, on clinical examination during the screening period
+Have grade 2 or greater neuropathy at the time of screening
+CTCAE grade 3 or higher peripheral neuropathy
+Grade >= 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Patients must not have > grade sensory neuropathy
+Pre-existing peripheral neuropathy of severity grade >= 2 (limiting instrumental activities of daily living)
+No baseline peripheral sensory neuropathy >= grade 2
+Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to enrollment
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Patient has ? grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Patients with evidence of >= grade 2 peripheral sensory neuropathy
+> Grade 1 peripheral neuropathy within 14 days before enrollment.
+Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
+Current grade 2 or higher peripheral neuropathy
+Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
+Uncontrolled neuropathy grade 2 or greater, regardless of cause
+Pre-existing neuropathy of >= grade 2
+Grade >= 2 peripheral neuropathy at baseline (within 21 days prior to cycle 1 day 1)
+Patients with peripheral neuropathy of > grade 1
+No peripheral edema >= grade 2 at baseline
+No peripheral neuropathy >= grade 2 at baseline
+Pre-existing grade >= 2 peripheral sensory neuropathy
+No prior evidence of grade 3 or greater ototoxicity or neuropathy
+No >= grade 2 sensory peripheral neuropathy
+Grade 2 or higher peripheral neuropathy.
+Significant neuropathy (grades 3–4, or grade 2 with pain)
+Neurological assessment for pre-existing peripheral neuropathy
+Must not have any significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to enrollment.
+Significant neuropathy (grades 3 to 4 or grade 2 pain)
+Peripheral sensory neuropathy at the thumbs bilaterally that interferes with function and/or activities of daily living
+Patients must not have grade 2 or greater peripheral sensory neuropathy
+RANDOMIZED PHASE II (ARMS K AND L): Patients must not have grade 2 or greater peripheral sensory neuropathy
+Peripheral neuropathy, if present, should be =< grade 1
+Sensory peripheral neuropathy >= grade 2
+Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function
+Significant neuropathy (grade 3, grade 4) at the time of the first dose and/or within 14 days before enrollment
+Peripheral neuropathy > grade 1 if due to brentuximab vedotin or any peripheral neuropathy > grade 2
+Peripheral neuropathy grade 0-2
+Recovery of all chemotherapy or radiation-related toxicities to grade =< 1, except for alopecia and peripheral neuropathy
+Patients with preexisting peripheral neuropathy >= grade 2 are ineligible
+Patients with grade >= 2 peripheral neuropathy
+Neuropathy (sensory and motor) =< to CTCAE grade 1
+Patients with symptomatic peripheral motor or sensory neuropathy >= grade 2 at baseline will receive radiation therapy alone
+For the bortezomib arm of the study, patients with grade >= 2 peripheral neuropathy
+Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
+Peripheral neuropathy > grade 1
+Patients with peripheral neuropathy greater than grade II
+Patients with grade 2 or higher peripheral neuropathy
+Peripheral neuropathy >= grade 1
+Pre-existing peripheral neuropathy CTCAE grade 2 or worse
+Neuropathy > Grade 1
+Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
+Has > Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy graded according to the Modified (\Balis\) Pediatric Scale of Peripheral Neuropathies
+participants with Grade 2 or higher residual toxicities from prior therapy (including Grade 2 or higher peripheral neuropathy or any grade neuropathy with pain; excluding alopecia). This includes recovery from any major surgery. Note: Participants with planned surgical to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery.
+Peripheral neuropathy >= grade 2 on clinical examination or grade 1 with pain during the screening period
+Has greater than or equal to (>=) Grade 2 peripheral neuropathy, or Grade 1 with pain on clinical examination during the screening period.
+Baseline peripheral sensory neuropathy ? grade 2
+Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior to randomization
+Has history of Grade 2 or greater peripheral neuropathy during the 3 months prior to enrollment.
+Patients who have experienced significant neuropathy (grades 3-4 or grade 2 with pain) within 14 days prior to registration are NOT eligible for participation
+Patient has peripheral neuropathy of Grade 3 or greater intensity, or painful Grade 2, as defined by the NCI CTC.
+Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity Criteria (CTC) version 4
+Patient with peripheral neuropathy Grade >2
+Grade 3 sensory neuropathy or motor neuropathy with pain
+Grade 2 or higher persisting prior treatment-related neuropathy
+Patients with grade 2 or greater peripheral neuropathy.
+CTCAE v4 Grade ?2 peripheral neuropathy
+Grade 2 or higher peripheral neuropathy
+Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
+Grade II or greater neuropathy at baseline
+Sensory/motor neuropathy >= grade 2
+Sensory/motor neuropathy >= grade 2
+Peripheral neuropathy >= grade 2 or clinically significant sensorineural hearing loss or tinnitus
+Paclitaxel arm: grade 2 or higher neuropathy
+Patients with any of the following adverse events at the time of enrollment are not eligible:\r\n* Grade ? 2 motor, sensory or peripheral neuropathy\r\n* Grade ? 3 hyponatremia (serum sodium [Na] ? 130 mmol/L)
+Patient has ? grade 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination during the screening period
+Current peripheral neuropathy >= grade 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
+Grade >= 2 peripheral neuropathy
+Preexisting peripheral neuropathy is not allowed from any cause
+Participant must have either no neuropathy (sensory and motor) or neuropathy less than or equal to grade 1
+Patients with persistent grade 2 or higher peripheral sensory or motor neuropathy of any cause
+Grade >= 2 peripheral neuropathy
+Pre-existing peripheral neuropathy grade ?= 2 at registration
+Patients with >= grade 2 neuropathy
+Sensory or motor peripheral neuropathy >= grade 2
+No grade >= 2 neuropathy
+Ongoing grade >= 3 neuropathy
+Grade 2 or higher peripheral neuropathy.
+>= grade 2 peripheral neuropathy
+Peripheral neuropathy >= grade 2 despite supportive therapy
+Sensory or motor neuropathy >= grade 2
+Central nervous system (CNS) toxicity including peripheral neuropathy =< grade 2
+Subject has preexisting sensory or motor neuropathy Grade ? 2 at baseline
+Subjects with grade 2 or greater neuropathy
+Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity
+Peripheral neuropathy of severity greater than grade 1
+Baseline of grade 2 or worse peripheral sensory neuropathy
+Motor peripheral neuropathy = grade 0 (per CTCAE v. 4.0)
+Greater than grade 1 peripheral neuropathy at baseline
+Peripheral neuropathy >= grade 3 on clinical examination or grade 2 with pain during the screening period
+Patients with existing grade 3 or 4 peripheral neuropathy
+Baseline neuropathy > grade 1
+Peripheral neuropathy >= grade 2 at baseline OR peripheral neuropathy >= grade I with neuropathic pain
+Patients with grade 3/4 peripheral neuropathy
+Patients who have baseline peripheral neuropathy >= grade 2 are not eligible
+Patient has baseline neuropathy of > grade 2
+Grade > 2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1)
+Subject has >= grade 2 peripheral neuropathy
+Peripheral neuropathy >= grade 2
+Grade 2 or higher peripheral neuropathy
+Patients must not have a pre-existing > grade 1 motor or sensory neuropathy
+PHASE II: Patients must not have a pre-existing > grade 1 motor or sensory neuropathy
+Patients with > grade 1 peripheral sensory neuropathy or > grade 1 peripheral motor neuropathy graded according to the Modified (“Balis”) Pediatric Scale of Peripheral Neuropathies are not eligible
+Patient has >= grade 2 peripheral neuropathy within 14 days of trial enrollment
+Patient has >= grade 3 peripheral neuropathy, or >= grade 2 with pain on clinical examination during the screening period
+Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
+Pre-existing grade 2 or greater neuropathy
+Grade 2 or greater neuropathy
+Pre-existing peripheral neuropathy > grade 2 with pain (CTC version 4.0).
+Neuropathy (sensory and motor) =< grade 1
+Peripheral neuropathy >= grade 2
+Peripheral neuropathy >= grade 2
+Peripheral neuropathy =< grade 1
+>= grade 2 peripheral neuropathy
+>= grade 2 peripheral neuropathy within 14 days before beginning maintenance therapy
+Pre-existing peripheral motor or sensory neuropathy >= grade 2
+Pre-existing grade >= 1 peripheral neuropathy
+Peripheral neuropathy >= grade 2 on clinical examination, within 21 days of initiation of protocol therapy
+Neuropathy (sensory and motor) less than or equal to Grade 1.
+Patients with >= grade 2 peripheral neuropathy
+Peripheral neuropathy grade 2 or greater
+Patients must not have grade 2 or higher peripheral neuropathy
+Participant with sensory peripheral neuropathy of ? Grade 2 at baseline, unable to swallow medication, or participants with prior history of seizure within the prior 12 months.
+Patients must not have peripheral neuropathy >= grade 2
+Patients with peripheral neuropathy > grade 2 regardless of etiology
+Has peripheral neuropathy ? Grade 2.
+Peripheral neuropathy >= grade 2 on clinical examination, within 21 days of initiation of protocol therapy
+Peripheral neuropathy =< grade 1
+Neuropathy Grade > 3
+Has peripheral neuropathy ? Grade 2
+Grade 2 or greater neuropathy [Applies to Phase 1]. Grade 3 or greater neuropathy [Applies to Phase 2].
+Subjects with baseline peripheral neuropathy that exceeds grade 1
+Significant symptoms (grade >= 2) peripheral neuropathy
+Preexisting sensory grade 3 neuropathy
+Pre-existing neuropathy of at least Grade 2
+Peripheral neuropathy ? Grade 3 or ? Grade 2 with pain within 2 weeks prior to first dose
+Peripheral neuropathy ? Grade 2
+Peripheral neuropathy ? Grade 2.
+Preexisting sensory neuropathy Grade ? 2 or motor neuropathy Grade ? 2
+Has peripheral neuropathy ? Grade 2
+Patients who have had grade 2 or higher peripheral neuropathy within 14 days prior to registration are not eligible (must have resolved to grade 1 or lower to register)
+Peripheral neuropathy or neuropathic pain Grade 2 or higher
+Current Grade >1 peripheral neuropathy
+Grade <= 2 neuropathy
+Grade ? 2 peripheral neuropathy
+Neuropathy uropathy europathy Nemediastinal DLBCL.
+Neurosensory neuropathy ? grade 2 at baseline.
+Less than Grade 2 pre-existing peripheral neuropathy
+Pre-existing neuropathy from any cause in excess of Grade 1.
+Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy
+Patients with > grade 1 neuropathy
+Peripheral neuropathy < grade 2
+Subjects with >= grade 2 neuropathy
+Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment and at D60-180 after AHCT; patients who had >= grade 2 peripheral neuropathy within 14 days before enrollment but resolves to grade 1 or lower peripheral neuropathy at D60-D180 after AHCT can be enrolled at this time
+Pre-existing peripheral neuropathy >= Common Terminology Criteria (CTC) grade 2 for those patients who received prior paclitaxel
+Known peripheral neuropathy > grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
+Grade >= 2 peripheral neuropathy
+Current Grade >1 peripheral neuropathy from any cause
+Evidence of ? Grade 2 neuropathy
+Patients must not have peripheral neuropathy > grade 2
+Peripheral neuropathy exclusions
+? Grade 2 peripheral neuropathy
+Baseline peripheral neuropathy/paresthesia grade >= 1
+Patient has >= grade 2 peripheral neuropathy
+Neuropathy > Grade 1.
+Patients with symptomatic neuropathy
+Patients with >= grade 2 neuropathy
+Patient has >= grade 2 peripheral neuropathy
+Sensory or motor peripheral neuropathy
+Grade 2 or greater neuropathy
+Patients must not have grade 2 or greater peripheral neuropathy
+Serious peripheral neuropathy.
+Uncontrolled neuropathy grade 2 or greater regardless of cause.
+Preexisting sensory grade >= 2 neuropathy
+Peripheral neuropathy- grade 2 or greater
+Peripheral neuropathy ? Grade 2.
+Patients must have < Grade 2 or pre-existing neuropathy (per CTCAE).
+Peripheral neuropathy grade 2 or greater
+Resolution of (non-laboratory) adverse effects of recent surgery, radiotherapy, or chemotherapy to grade =<1 prior to first study treatment (with the exception of alopecia or neuropathy; chemotherapy-induced peripheral neuropathy up to grade =< 2 will be permitted)
+Pre-existing Grade greater than (>) 1 neuropathy
+Patient has >= grade 1 peripheral neuropathy with pain on clinical examination during the screening period
+Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
+Participants who have more than grade 1 peripheral neuropathy
+Current peripheral sensory neuropathy > grade 1
+Peripheral neuropathy >= grade 2
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Neuropathy grade 2 or higher
+Peripheral neuropathy < grade 2
+Neuropathy (sensory and motor) less than or equal to grade 1
+Significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to enrollment
+Significant neuropathy (? Grade 3) within the 14 days prior to randomization
+Clinically significant peripheral neuropathy
+Has baseline peripheral neuropathy/paresthesia grade ? 1.
+Participant has >= grade 2 peripheral neuropathy on clinical examination within 21 days before initiation of protocol therapy
+Evidence of peripheral neuropathy of Grade >2.
+Grade 2 or higher peripheral neuropathy (paclitaxel arm only)
+Pre-existing peripheral neuropathy (grade I or higher)
+Patients with grade 2 peripheral neuropathy or greater are excluded
+Patients with Grade 2 or greater pre-existing neurologic abnormalities (CTCAE version 4.0), including Grade 2 or greater peripheral neuropathy caused by previous treatments.
+Neuropathy (sensory and motor) less than or equal to grade 1
+Significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to enrollment
+Subjects with >= grade 2 neuropathy
+Subject has peripheral neuropathy ? grade 2.
+Peripheral neuropathy >= grade 1
+Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy
+Grade 3 or above peripheral neuropathy
+Peripheral neuropathy: must be =< grade 1
+Grade > 2 peripheral neuropathy at baseline
+Grade >= 2 peripheral neuropathy within 14 days prior to cycle 1 day 1
+Patients with existing peripheral neuropathy grade > 2
+Preexisting sensory and/or motor neuropathy Grade ? 2
+Peripheral neuropathy =< grade 1 at the time of registration
+Existence of peripheral sensory neuropathy >= grade 2 (from any cause)
+The patient has peripheral neuropathy >= grade 2
+Patients with grade II or greater peripheral neuropathy will be excluded from study
+Grade >= 2 peripheral neuropathy within 14 days prior to initiation of therapy
+Patient has > grade 2 peripheral neuropathy on clinical examination during the screening period
+Subject has peripheral neuropathy >= grade 2.
+Presence of peripheral neuropathy ? CTCAE Grade 2
+Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to the first day of treatment
+Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
+Neurosensory neuropathy ? grade 2 at baseline
+No significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to cycle 1 day 1
+Peripheral neuropathy ? Grade 2 despite supportive therapy
+Participant has >= grade 2 peripheral neuropathy on clinical examination within 21 days before initiation of protocol therapy
+Significant neuropathy >= grade 3 or grade 2 neuropathy with pain at baseline
+Has baseline peripheral neuropathy/paresthesia
+COHORT II: Patients must not have >= grade 2 peripheral neuropathy
+Significant neuropathy >= grade 3 or grade 2 neuropathy with pain at baseline
+Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to signing consent
+Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
+Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of first dose
+> Grade 3 neuropathy
+Peripheral neuropathy > Grade 2.
+Current grade II or higher peripheral neuropathy.
+Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose
+Subjects with pre-existing grade 3 or 4 neuropathy; any peripheral neuropathy must recover to grade =< 1 before enrollment
+Patients with grade 2 sensory neuropathy at baseline
+Pre-existing grade 3 or 4 sensory neuropathy
+Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
+Grade >= 2 peripheral neuropathy within 21 days before enrollment
+Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
+Significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to enrollment
+Patient has >= grade 3 peripheral sensory neuropathy or >= grade 2 painful sensory neuropathy within 14 days before enrollment; (NOTE: patient with peripheral neuropathy [PN] that was previously this severe but is currently improved due to ongoing therapy [e.g., gabapentin or amitriptyline] may be eligible)
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+CTC Grade 1 or greater neuropathy (motor or sensory) from comorbidity other than prior taxane exposure, such as diabetes.
+Pre-existing neuropathy greater than grade 1
+Patients with greater than or equal to grade 2 peripheral neuropathy at baseline
+Patient must not have >= grade 2 peripheral neuropathy within 14 days before enrollment
+Patient has >= grade 2 peripheral neuropathy
+Pre-existing neuropathy greater than grade 1.
+Pre-existing neuropathy grade III or greater
+Grade >= 2 sensory neuropathy at the time of enrollment
+No peripheral or sensory neuropathy > grade 1 at study entry
+Grade >1 neuropathy
+Preexisting sensory grade >= 2 neuropathy
+Peripheral neuropathy greater than Grade 1
+Peripheral neuropathy >= grade 2 at baseline OR peripheral neuropathy >= grade I with neuropathic pain
+Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
+Pre-existing neuropathy from any cause in excess of Grade 1
+No peripheral neuropathy greater than grade 1, due to any cause
+Patient has >= grade 2 (CTCAE v 4.0) peripheral neuropathy within 14 days before enrollment
+History of Grade ?2 neuropathy
+Patient has >= grade 2 peripheral neuropathy on clinical examination within 28 days of signing consent
+Peripheral neuropathy: must be =< grade 1
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Grade 2 or more peripheral neuropathy
+Peripheral neuropathy of grade >=3. Patients with painful grade 2 neuropathy are also excluded
+Peripheral neuropathy ? Grade 2
+Patient has baseline neuropathy of >= grade 2
+Peripheral neuropathy >= grade 3
+Neuropathy (sensory and motor) less than or equal to grade 1
+Significant peripheral neuropathy defined as grade 2 or higher
+No ? grade 2 peripheral neuropathy.
+Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
+Neuropathy > grade 2
+Patient has > = Grade 2 peripheral neuropathy within 14 days before enrollment.
+CTCAE version 4.03 > grade 3 peripheral neuropathy
+Peripheral neuropathy =< grade 1
+Significant neuropathy >= grade 3 or grade 2 neuropathy with pain at baseline
+Patient has grade 3 peripheral neuropathy or grade 2 with pain on clinical examination during the screening period
+Pre-existing peripheral neuropathy >= grade 2
+Peripheral neuropathy >= grade (Gr) II
+Subject has > grade 2 peripheral neuropathy within 14 days before enrollment
+? Grade-2 neuropathy
+Grade >= 2 peripheral neuropathy within 14 days before enrollment
+Peripheral neuropathy =< grade 1
+Peripheral neuropathy >/= Grade 2 (NCI-CTC Version 3.0)
+Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.
+No grade 2 >= peripheral neuropathy within 14 days before enrollment
+?Grade 2 sensory neuropathy at baseline
+Neuropathy (sensory and motor) less than or equal to CTCAE v 4.0 grade 1
+Grade 3 peripheral neuropathy
+Patient has >= grade 2 peripheral neuropathy
+Patients with peripheral neuropathy of grade >= 3; patients with painful grade 2 neuropathy are also excluded
+No current grade 2, 3, or 4 of neuropathy
+Peripheral neuropathy
+Patient has >= grade 3 peripheral neuropathy, or grade 2 peripheral neuropathy with pain on clinical examination during the screening period
+Peripheral neuropathy > grade 2
+Current grade II or higher peripheral neuropathy.
+Peripheral neuropathy that is grade 2 or higher
+All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade </= 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+> grade 2 peripheral neuropathy at baseline
+Peripheral neuropathy of grade 2 or greater
+Presence of ? Grade 2 peripheral neuropathy
+Peripheral neuropathy ? Grade 3.
+Presence of clinically significant non-hematological toxicity of prior chemotherapy that has not resolved to ? Grade 1 as determined by CTCAE v 4.0, with the exception of alopecia and peripheral neuropathy. Note: Peripheral neuropathy > Grade 2 plus pain, or Grade 3 or Grade 4 are excluded.
+Evidence of baseline sensory or motor neuropathy
+Presence of > Grade 1 peripheral neuropathy
+Grade 3 or higher peripheral neuropathy
+Peripheral neuropathy CTCAE Grade ?2
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Peripheral neuropathy ? Grade 2
+Patients with any neuropathy > Grade 1
+Patients with grade > 2 neuropathy attributable to previous administration of taxane chemotherapy
+Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to enrollment
+have persistent Grade 2 or greater toxicities from any cause (except alopecia or peripheral neuropathy).
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening
+Peripheral edema > grade 1
+Patients with peripheral neuropathy > 2
+Baseline peripheral neuropathy ? grade 2.
+Sensory peripheral neuropathy greater than or equal to (>/=) Grade 2
+Clinical evidence of neuropathy
+Peripheral neuropathy ? grade 2.
+Grade >= 2 peripheral neuropathy
+Evidence of sensory and/or peripheral neuropathy > grade 1
+If applicable, patient has >= Grade 2 peripheral neuropathy within 14 days before enrollment
+Neuropathy (sensory and motor) =< CTCAE v4.03 grade 1
+Significant neuropathy >= grade 3 at baseline
+Peripheral neuropathy greater than grade 1
+Patients with grade >= 2 peripheral neuropathy will not be permitted on study
+Patients with any neuropathy.
+Patients with preexisting peripheral neuropathy grade >= 2 will not be eligible
+Grade ? 2 sensory neuropathy
+Evidence of peripheral neuropathy of Grade > 2
+Subjects with > grade 1 peripheral neuropathy
+Significant peripheral sensory or motor neuropathy at the start of the study.
+Patients with > grade 2 neuropathy according to the Modified (“Balis”) Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery
+Patients with neuropathy > grade 1
+Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to Day 1
+Peripheral neuropathy Grade >/=2
+Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment
+Grade 2 or higher neuropathy
+Current/ongoing Neuropathy (sensory or motor) Grade > 1 or any history of Grade ? 3 neuropathy with prior Vincristine or chemotherapy exposure (documentation by history is adequate to exclude)
+Presence of peripheral neuropathy
+Greater than grade 2 motor neuropathy or greater than grade 3 sensory neuropathy at screening
+Subject has Neuropathy ? Grade 2 at Screening.
+Subjects with Grade >2 peripheral neuropathy
+Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per Criteria for Adverse Events (CTCAE) v4.0).
+Peripheral neuropathy at study entry
+>= grade 2 pre-existing peripheral neuropathy (per CTCAEv4)
+Peripheral neuropathy CTCAE v4.03 Grade ? 3
+Patients with peripheral neuropathy >= grade 2
+Patients with greater than 2 screening peripheral neuropathy
+Peripheral neuropathy ? CTCAE Grade 2 at baseline.
+Sensory peripheral neuropathy greater than or equal to (>/=) Grade 2
+Patients who have grade >= 2 peripheral neuropathy
+Preexisting grade >= 2 peripheral neuropathy
+Patients with peripheral neuropathy >= grade 2 are not permitted unless discussed with the principal investigator and only in unique circumstances (i.e. unilateral neuropathy due to trauma)
+With < or = grade 2 neuropathy
+> grade 2 neuropathy
+Current grade 3 or higher neuropathy
+Grade 2 or higher peripheral neuropathy
+Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment.
+Grade ? 2 sensory neuropathy
+Patients with grade III-IV neuropathy
+Significant neuropathy (grades 3 to 4, or grade 2 pain)
+No grade >= 2 peripheral neuropathy
+Patient has >= grade 2 peripheral neuropathy
+Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to randomization
+Grade 2 or above neuropathy
+Grade >=2 peripheral neuropathy
+Presence of ? Grade 2 neuropathy.
+Baseline peripheral edema >= grade 3
+Pre-existing peripheral neuropathy grade >= 2
+Neuropathy Grade 3 or more
+Part 2 only: Patients with >= grade 2 peripheral neuropathy.
+If applicable, patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
+Significant peripheral neuropathy (Grade 3, Grade 4, or Grade 2 with pain) within 14 days prior to first dose
+Grade 2 or higher peripheral neuropathy at the time of study entry
+Peripheral neuropathy ?Grade 2.
+Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior to randomization
+>= grade 2 peripheral neuropathy
+Peripheral neuropathy >= grade 2 on clinical examination during the screening period
+Peripheral neuropathy
+Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before study treatment
+Patients with a >= grade 2 peripheral neuropathy
+Current Grade >1 peripheral neuropathy
+History of peripheral neuropathy; (note: this does not apply to Cohort 3)
+Grade >=2 peripheral neuropathy
+Patients with peripheral neuropathy >= grade 2
+Grade ?2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
+Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization.
+Current peripheral neuropathy of NCI-CTC, version 4.0 Grade 3 or greater
+Grade 2 or greater peripheral neuropathy
+Peripheral neuropathy >= grade 2
+Patient has >= grade 2 peripheral neuropathy within 14 days prior to treatment initiation
+Peripheral neuropathy that is greater or equal to Grade 2
+Has peripheral neuropathy that is greater or equal to Grade 2
+Pre-existing peripheral neuropathy greater than CTCAE Grade 2.
+Patient has > Grade 2 painful neuropathy or peripheral neuropathy
+Peripheral neuropathy ? Grade 2
+Patients with peripheral neuropathy > grade 1 will be excluded from study participation
+The participant has any Grade 2 (or greater) peripheral neuropathy.
+Evidence of grade 2 or greater sensory and/or peripheral neuropathy
+Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
+Pre-existing >= grade 2 peripheral neuropathy
+Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization
+No grade 2 or greater peripheral neuropathy.
+Grade >= 2 neuropathy
+History of peripheral neuropathy of ?grade 2
+Patients with symptomatic peripheral neuropathy> Grade 1.
+No evidence of peripheral or sensory neuropathy
+Grade 2 or greater motor or sensory neuropathy
+Patient does not have a clinically significant neurologic deficit or objective peripheral neuropathy (greater than or equal to grade 2); peripheral (sensory or motor) neuropathy related to limb sparing procedure or amputation is allowed
+Peripheral neuropathy > grade 1 (NCI-CTC).
+Peripheral neuropathy of > grade 2 severity.
+Peripheral neuropathy ? CTCAE grade 2
+Peripheral neuropathy with grade =< 1
+Neuropathy >= grade 2 (moderate neuropathy that limits instrumental activities of daily living)
+Clinically significant (>= grade 2) peripheral neuropathy at the time of study entry
+Patients with >= grade 2 sensory or motor neuropathy are not eligible
+Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to enrollment
+Neuropathy (sensory or motor) less than or equal to grade 1
+Patient has pre-existing peripheral neuropathy Grade >1
+Peripheral neuropathy >= grade 1
+Grade >= 2 peripheral neuropathy
+Patients must not have a history of peripheral neuropathy (regardless of cause)
+Pre-existing symmetric peripheral painful neuropathy
+Any peripheral neuropathy >= grade 3
+Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy
+Grade III or IV upper extremity peripheral neuropathy
+Self-report of >= 4 on the Peripheral Neuropathy Question
+Presence of pain primarily due to chemotherapy induced peripheral neuropathy
+Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy.
+History of peripheral neuropathy prior to receiving neurotoxic chemotherapy
+Pain or symptoms of peripheral neuropathy of > 3 month's duration attributed to chemotherapy-induced peripheral neuropathy
+SCREENING PHASE: Pre-existing peripheral neuropathy within 28 days of screening consent
+INTERVENTION PHASE: Pre-existing peripheral neuropathy within 28 days of screening consent
+Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
+Pre-existing grade 2 or greater neuropathy
+Neuropathy: no baseline neuropathy grade > 2
+Peripheral neuropathy greater than or equal to grade 2.
+History of pre-existing peripheral neuropathy prior to chemotherapy, including alcoholism, vitamin B deficiency, diabetes, human immunodeficiency virus (HIV), congenital neuropathy, toxic neuropathy
+Known diabetic neuropathy
+Patient with >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Grade 2 or higher peripheral neuropathy
+Grade II or higher neuropathy
+No >= grade 2 peripheral neuropathy
+Peripheral neuropathy ? grade 2
+Peripheral neuropathy greater than grade 1
+Patients with > grade 2 sensory peripheral neuropathy
+Patients with ? grade 2 sensory peripheral neuropathy
+Sensory/motor neuropathy ? Grade 2
+Have pre-existing peripheral neuropathy from other medical conditions or due to cancer
+Greater than Grade 2 neuropathy or ? Grade 2 neuropathy with pain at baseline, regardless of whether or not the patient is currently receiving medication
+Peripheral neuropathy greater than grade 1
+Pre-existing sensory neuropathy > grade 1
+Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
+Neuropathy with or without pain
+Current or prior history of grade ? 2 peripheral sensory and/or motor neuropathy.
+Has neuropathy ? Grade 2.