Nervous system disorders (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version .) resulting from prior therapy must be =< grade with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
Diarrhea >= grade , based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) categorization within days of registration
Diarrhea, grade or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version [v] .)
Residual toxicity from prior therapy grade > (National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v] .) that could interfere with study endpoints or put patient safety at risk
Subjects with >= grade peripheral neuropathy at enrollment per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
EXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Clinically significant peripheral neuropathy at the time of enrollment (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version . [CTCAE v.] as grade or greater neurosensory or neuromotor toxicity)
EXCLUSION CRITERIA FOR THIRD-LINE THERAPY: Clinically significant peripheral neuropathy at the time of enrollment (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version . [CTCAE v.] as grade or greater neurosensory or neuromotor toxicity)
Persistent diarrhea or malabsorption National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade , despite medical management
Moderate-to-severe bone pain (i.e., National Cancer Institute's Common Terminology Criteria for Adverse Events grade - bone pain).
Neuropathy >= grade or painful neuropathy >= grade (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v].)
Absolute neutrophil count (ANC) greater than or equal to ,/mcl, equivalent to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version . (CTCAE v.) grade
Peripheral neuropathy of Grade greater than or equal to (>/=) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version . or ., as utilized in the parent study
Persistent grade > (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v].) adverse events (AEs) due to investigational drugs that were administered more than days before registration
All non-hematological adverse events related to any prior chemotherapy, surgery, or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade less than or equal to (</=) prior to starting therapy Alectinib
Persisting toxicity related to prior therapy > Grade National Cancer Institute Common Terminology Criteria for Adverse Events, version . (NCI-CTCAE v.); however, sensory neuropathy ? Grade is acceptable.
Diarrhea > grade according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v).
Diarrhea > grade , based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading, in the absence of antidiarrheals
History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias > Grade (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version .), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion restrictive cardiomyopathy) within months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
Diarrhea > grade , based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrheals
Patient must not have any active, uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as >= grade based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v). (CTCAE)
Any abnormality that would be scored as National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . (v .) grade IV toxicity that is unrelated to HIV, its treatment, or to MCD that would preclude protocol treatment and/or observation only
Concurrent disease or condition that would interfere with study participation or safety, such as any of the following: \r\n* Active, clinically significant infection either grade > by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. or requiring the use of parenteral anti-microbial agents within days before day of study drug.\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders non-healing wound, ulcer, or bone fracture.
TREATMENT WITH SJCAR: Has recovered from all National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade III-IV, non-hematologic acute toxicities from prior therapy
History of, or known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ? drug-related CNS toxicity
Unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version .), New York Association class III or IV heart failure
Diarrhea > grade based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) in the absence of antidiarrheals
Grade >= neuropathy (National Cancer Institute [NCI] CTCAE version )
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . grade hemorrhage within weeks of starting the study treatment
Peripheral edema >= grade per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version .
Subjects must have recovered to =< grade National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . or stabilized from toxicity of prior chemotherapy or biologic therapy administered more than weeks or half-lives earlier, whichever is shorter
Active uncontrolled infection National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Grade greater than or equal to ).
Clinically significant peripheral neuropathy at the time of enrollment (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v.) as grade or greater neurosensory or neuromotor toxicity)
Diarrhea > grade , based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) . grading, in the absence of antidiarrheals
Absence of clinically significant bradycardia, or other uncontrolled cardiac arrhythmia defined as grade or according to National Cancer Institute (NCI) Common Terminology
No dehydration of National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade >=
Grade >= peripheral neuropathy according to (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) version .
Haematological and liver function test results ? grade toxicity (according to US National Cancer Institute's Common Terminology) Criteria for Adverse Events v. [CTCAE
Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ? or baseline (except alopecia or neuropathy)
Peripheral neuropathy of grade >= per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version ., at the time of or within weeks prior to the first study therapy
Active known clinically serious infections (> grade National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version .)
Presence of peripheral neuropathy >= grade based on National Cancer Institute Common Terminology Criteria for Adverse Events version . (NCI CTCAE v .)
Any previous venous thromboembolism > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade
Diarrhea > grade , based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrheals
Patients who have not recovered from adverse events of prior therapy to =< National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v). grade
Ongoing >= grade cardiac, pulmonary, renal, gastrointestinal or hepatic toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version toxicity criteria
Any active grade or higher (per the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version .) viral, bacterial, or fungal) infection within two weeks prior to the first dose of study treatment
Peripheral neuropathy grade or by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version .
Active known clinically serious infections (> grade National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] version .)
All AEs of any prior chemotherapy, surgery, or radiotherapy not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version [v.].) grade =<
Concurrent disease or condition that would interfere with study participation or safety, such as any of the following:\r\n* Active, clinically significant infection either grade > by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v). or requiring the use of parenteral anti-microbial agents within days before day of study drug\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders\r\n* Non-healing wound, ulcer, or bone fracture
Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v . grade ?.
Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) grade =< or baseline (except alopecia or neuropathy)
Unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version .), New York Association class III or IV heart failure
Concurrent disease or condition that would interfere with study participation or safety, such as any of the following:\r\n* Active, clinically significant infection either grade > by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v). or requiring the use of parenteral anti-microbial agents within days before day of study drug\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders
Any other serious illness or medical condition, such as but not limited to:\r\n* Any infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version . grade \r\n* Cardiac failure New York Heart Association (NYHA) III or IV\r\n* Crohns disease or ulcerative colitis\r\n* Known bone marrow dysplasia
Persistent clinically significant toxicity from prior chemotherapy that is Grade or higher by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (v.).
Peripheral neuropathy of grade or greater severity as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version .; patients with grade or higher (NCI-Common Toxicity Criteria [CTC]) neuropathy
Clinically significant peripheral neuropathy at the time of randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version . [CTCAE v.] as grade or greater neurosensory or neuromotor toxicity)
Diarrhea > grade , based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, or currently taking antidiarrheals
Potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) > grade
Presence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ? grade toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? NCI CTCAE grade ) due to prior cancer therapy
Active or uncontrolled infection (National Cancer Institute (NCI)-CTCAE Grade ? ).
Peripheral neuropathy of any etiology > grade (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version .)
No pre-existing neuropathy grade > per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version .
Peripheral edema >= grade per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version .
Electrolytes =< grade severity according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version . or if judged clinically not significant by the investigator
No evidence of ongoing cardiac dysrhythmia >= grade (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], version [v].)
No evidence of ongoing cardiac dysrhythmia >= grade (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], v .)
No clinically significant (equivalent to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] grade -) bleeding episodes within the past months
Subject has any peripheral neuropathy ? NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events ) Grade at randomization/enrollment.
Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . grade >=
Patients must not currently have a > grade symptomatic neuropathy-sensory (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version .)
Clinically significant toxicity from prior therapy that has not resolved to Grade <= (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], v.) prior to Day of Cycle
Any peripheral neuropathy ? National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade .
National Cancer Institute (NCI) Common Terminology criteria for Adverse Events (CTCAE) Grade hemorrhage within days before Screening
Persistent diarrhea or malabsorption >= National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade , despite medical management
Concurrent disease or condition that would interfere with study participation or safety, such as any of the following: \r\n* Active, clinically significant infection either grade > by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v). or requiring the use of parenteral anti-microbial agents within days before day of study drug \r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders \r\n* Non-healing wound, ulcer, or bone fracture
Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) .
Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACE) version . grade >= ; however, stable atrial fibrillation controlled medically or with a device (e.g. pacemaker) or prior ablation is allowed
Any unresolved toxicity Grade or more according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy
Potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) > grade
Any previous National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade venous thromboembolism
Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade less than/equal to or baseline (except alopecia)
Ongoing or active infection (bacterial, fungal, or viral) of National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version . Grade > .
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . grade hemorrhage within weeks of starting the study treatment
Persistent diarrhea or malabsorption > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade , despite medical management
significant cardiovascular disease within the last months including: myocardial infarction, unstable angina, congestive heart failure, ongoing arrhythmias of Grade > [National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version .], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
Ongoing infection > grade National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version .
Following medical conditions are not eligible:\r\n* Other malignancy treated within the last years (except non melanoma skin cancer or low-grade superficial bladder cancer or cervical dysplasia)\r\n* Any other serious illness or medical condition, such as but not limited to: \r\n** Any infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version . grade \r\n** Cardiac failure New York Heart Association (NYHA) III or IV\r\n** Crohns disease or ulcerative colitis\r\n** Bone marrow dysplasia or myelodysplastic syndrome
Peripheral edema >= grade per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version .
Persistent grade > (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v].) adverse events (AEs) due to investigational drugs that were administered more than days before study enrollment with the exception of alopecia
Any other serious illness or medical condition in the opinion of the investigator, such as but not limited to:\r\n* Any grade >= infection as defined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version . \r\n* Cardiac failure New York Heart Association (NYHA) III or IV\r\n* Crohns disease or ulcerative colitis\r\n* Bone marrow dysplasia\r\n* Fecal incontinence
Participant has peripheral neuropathy or neuropathic pain Grade or higher, as defined by the national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version
Recovered from toxicities related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v.) grade ?.
The patient has ? Grade peripheral neuropathy by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) at screening
Pre-existing neuropathy >= grade (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version .)
Ongoing infection > grade according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version . (CTCAE v. .)
Any other serious illness or medical condition, such as but not limited to: Any active infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version . Grade ; Cardiac failure New York Heart Association (NYHA) III or IV; Fecal incontinence (this is because of Ra- elimination in feces).
Clinically significant active gastrointestinal (GI) bleeding (Grade >/= according to National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version . [CTCAEv..])
Ongoing infection > Grade according to NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) v. .. Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required.
Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . grade >=
Previous radiation allowed provided the patient has recovered from the acute and chronic side effects to =< grade (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events v. . [CTCAE v .])
Diarrhea > grade , based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrheals
E . Symptomatic peripheral neuropathy grade > (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v..).
Ongoing infection > grade according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version . (CTCAE v. .)
Resolution of any pre-existing toxicity from prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version . =< grade except neuropathy (=< grade ) and tinnitus (=< grade ), and hearing loss (=< grade )
Clinically significant peripheral neuropathy at the time of randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version . [CTCAE v.] as grade or greater neurosensory or neuromotor toxicity)
Active clinically serious infections [> Grade National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version .]
Patients who have not recovered from adverse events of prior therapy to =< National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v). grade
Pre-existing peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] ?)
Clinically significant peripheral neuropathy at the time of randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version . [CTCAE v.] as grade or greater neurosensory or neuromotor toxicity)
Ineligible for cisplatin-based chemotherapy as defined by any one of the following criteria: Impaired renal function (glomerular filtration rate [GFR] > but < milliliter/minute [mL/min]); National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) . Grade >= audiometric hearing loss (of Decibel at two contiguous frequencies or more severe); NCI CTCAE v . Grade >= peripheral neuropathy; ECOG Performance Status of
Peripheral neuropathy of grade >= per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version ., at the time of or within weeks prior to the first study therapy
Have peripheral neuropathy of grade or grade at screening, according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version (v)., June scale; or Total Neuropathy Scoreclinical (TNSc) score greater than
Ongoing cardiac dysrhythmia >= (per National Cancer Institute Common Terminology Criteria for Adverse Events version . [NCI CTCAE, v.])
Current peripheral neuropathy of grade >= per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. .
All non-hematological adverse events of any prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade less than or equal to (</=) prior to starting therapy
Participants with evidence of electrolyte imbalance such as hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypomagnesemia, and hypermagnesemia of Grade > intensity, as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version ., prior to dosing on Cycle Day . Treatment for correction of electrolyte imbalances is permitted to meet eligibility
Neuropathy ? Grade or painful neuropathy ? Grade (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v.).
Any other serious illness or medical condition, such as but not limited to: \r\n* Any infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version . grade \r\n* Cardiac failure New York Heart Association (NYHA) III or IV \r\n* Crohns disease or ulcerative colitis \r\n* Bone marrow dysplasia \r\n* Fecal incontinence
Any vomiting, retching or National Cancer Institute (NCI) Common Toxicity Criteria version . grade - nausea hours preceding chemotherapy
Known history of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version .) grade >= symptomatic chronic heart failure (CHF), myocardial infarction within months prior to randomization, significant symptoms (grade >= ) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (grade >= )
Peripheral neuropathy grade or by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version .
Any vomiting, retching, or National Cancer Institute (NCI) Common Toxicity Criteria version . grade - nausea in the hours(hrs.) preceding radiation and chemotherapy
The participant has not recovered from Adverse Events due to agents administered more than weeks earlier. Neurotoxicity, if present, must have improved to Grade less than per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v ..
The participant has not recovered from adverse events due to agents administered more than weeks earlier. Neurotoxicity, if present, must have improved to Grade less than per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v ..
Patients who have an active clinically significant infection of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade ?