Nervous system disorders (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI 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
No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec
Diarrhea >= grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) categorization within 14 days of registration
Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version [v] 4.0)
Residual toxicity from prior therapy grade > 1 (National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0) that could interfere with study endpoints or put patient safety at risk
Persistent diarrhea or malabsorption National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2, despite medical management
Moderate-to-severe bone pain (i.e., National Cancer Institute's Common Terminology Criteria for Adverse Events grade 2-3 bone pain).
Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug, including but not limited to:\r\n* Deep vein thrombosis\r\n* Pulmonary embolism\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Peripheral arterial ischemia > grade 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.03)
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) grade 1
Persistent grade > 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) adverse events (AEs) due to investigational drugs that were administered more than 14 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 (</=) 2 prior to starting therapy Alectinib
Diarrhea > grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03
Diarrhea > grade 1, 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 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
Diarrhea > grade 1, 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 3 based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v)4.0 (CTCAE)
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 > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug.\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders non-healing wound, ulcer, or bone fracture.
Unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 5.0), New York Association class III or IV heart failure
Diarrhea > grade 1 based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) in the absence of antidiarrheals
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 3 hemorrhage within 4 weeks of starting the study treatment
Peripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Active uncontrolled infection National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Grade greater than or equal to 3).
Diarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 grading, in the absence of antidiarrheals
Absence of clinically significant bradycardia, or other uncontrolled cardiac arrhythmia defined as grade 3 or 4 according to National Cancer Institute (NCI) Common Terminology
No dehydration of National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade >= 1
Haematological and liver function test results ? grade 2 toxicity (according to US National Cancer Institute's Common Terminology) Criteria for Adverse Events v4.03 [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 ? 1 or baseline (except alopecia or neuropathy)
Active known clinically serious infections (> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03)
Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or grade >= 2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline)
Not recovered to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 grade =< 1 from adverse events (AEs) (except alopecia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug
Any previous venous thromboembolism > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 3
Diarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrheals
Lack of recovery of prior adverse events to grade =< 1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v] 4.03) (except alopecia) due to therapy administered prior to the initiation of study drug dosing; stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the investigator
Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or grade >= 2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline)
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)4.0 grade 1
Any active grade 3 or higher (per the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.03) viral, bacterial, or fungal) infection within two weeks prior to the first dose of study treatment
Active known clinically serious infections (> grade 2 National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] version 4.03)
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.]4.0) grade =< 2
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 > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 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
Subjects being enrolled to receive paclitaxel plus carboplatin treatment must have neuropathic function (sensory and motor less than or equal to Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (2010)
Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) grade =< 1 or baseline (except alopecia or neuropathy)
Unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.03), 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 > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 or requiring the use of parenteral anti-microbial agents within 7 days before day 1 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 4.03 grade 2\r\n* Cardiac failure New York Heart Association (NYHA) III or IV\r\n* Crohn’s disease or ulcerative colitis\r\n* Known bone marrow dysplasia
Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (v4.03).
The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) grade =< 1 from adverse events (AEs) (except alopecia, anemia, and lymphopenia) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study
Diarrhea > grade 1, 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 1
Active or uncontrolled infection (National Cancer Institute (NCI)-CTCAE Grade ? 2).
Total calcium (corrected for serum albumin) within institutional normal limits, or =< grade 1 according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 if judged clinically not significant by the investigator (bisphosphonate use for malignant hypercalcemia control is not allowed)
Peripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Electrolytes =< grade 1 severity according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or if judged clinically not significant by the investigator
No evidence of ongoing cardiac dysrhythmia >= grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], version [v]4.0)
No evidence of ongoing cardiac dysrhythmia >= grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], v 4.0)
No clinically significant (equivalent to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] grade 3-4) bleeding episodes within the past 3 months
Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn's disease, malabsorption, or Grade ?2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline)
Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade >= 2
Clinically significant toxicity from prior therapy that has not resolved to Grade <=2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.0) prior to Day 1 of Cycle 1
National Cancer Institute (NCI) Common Terminology criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within 28 days before Screening
Persistent diarrhea or malabsorption >= National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2, 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 > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 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) 4.0
Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACE) version 4.0 grade >= 2; however, stable atrial fibrillation controlled medically or with a device (e.g. pacemaker) or prior ablation is allowed
Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or grade >= 2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v.4.0 diarrhea of any etiology at baseline)
Potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) > grade 1
Any previous National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 4 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 1 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 4.03 Grade > 2.
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 3 hemorrhage within 4 weeks of starting the study treatment
Persistent diarrhea or malabsorption > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2, despite medical management
significant cardiovascular disease within the last 3 months including: myocardial infarction, unstable angina, congestive heart failure, ongoing arrhythmias of Grade >2 [National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
Ongoing infection > grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Following medical conditions are not eligible:\r\n* Other malignancy treated within the last 3 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 4.03 grade 2\r\n** Cardiac failure New York Heart Association (NYHA) III or IV\r\n** Crohn’s disease or ulcerative colitis\r\n** Bone marrow dysplasia or myelodysplastic syndrome
The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 grade =< 1 from adverse events (AEs) (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug
Peripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Persistent grade > 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) adverse events (AEs) due to investigational drugs that were administered more than 14 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 >= 2 infection as defined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 \r\n* Cardiac failure New York Heart Association (NYHA) III or IV\r\n* Crohn’s disease or ulcerative colitis\r\n* Bone marrow dysplasia\r\n* Fecal incontinence
Participant has significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or grade >= 2 [National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0] diarrhea of any etiology at screening)
Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug, including but not limited to:\r\n* Deep vein thrombosis\r\n* Pulmonary embolism\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Peripheral arterial ischemia > grade 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)
Ongoing infection > grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0)
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 4.03 Grade 2; Cardiac failure New York Heart Association (NYHA) III or IV; Fecal incontinence (this is because of Ra-223 elimination in feces).
Clinically significant active gastrointestinal (GI) bleeding (Grade >/=2 according to National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version 4.0 [CTCAEv.4.0])
Ongoing infection > Grade 2 according to NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) v. 4.0. 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 4.0 grade >= 2
Previous radiation allowed provided the patient has recovered from the acute and chronic side effects to =< grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events v. 4.0 [CTCAE v 4.0])
Diarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrheals
E 04. Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
Ongoing infection > grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0)
Lack of recovery of prior adverse events to Grade ?1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events version 4) (except alopecia) due to therapy administered prior to the initiation of study drug dosing.
Active clinically serious infections [> Grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0]
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)4.0 grade 1
Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0) at the time of randomization.
Recovery from all reversible AEs of previous medical therapies to baseline or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 1, except for alopecia (any grade)
Ongoing cardiac dysrhythmia >= 2 (per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [NCI CTCAE, v4.0])
Patients with serious medical illness, including but not limited to: history of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.02), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug, or New York Heart Association class III or IV heart failure; chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
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 (</=) 2 prior to starting therapy
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 4.0 grade 2\r\n* Cardiac failure New York Heart Association (NYHA) III or IV \r\n* Crohn’s disease or ulcerative colitis \r\n* Bone marrow dysplasia \r\n* Fecal incontinence
Known history of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade >= 2 symptomatic chronic heart failure (CHF), myocardial infarction within 12 months prior to randomization, significant symptoms (grade >= 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (grade >= 3)
The participant has not recovered from Adverse Events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.
The participant has not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.
Patients who have an active clinically significant infection of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade ? 2