Therapeutic procedure Quantity Completed | Clinical Trial Specified
Item
complete 6 cycles treatment in preceding phase i/ii study
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Therapeutic procedure Quantity | Response In complete remission | Partial response | Minimal therapeutic response | Response No change | Effect Against Neoplasm | Pain relief | Performance status Improved
Item
response (cr, pr, mr or nc) was obtained in 6 cycles treatment during the preceding phase i/ii study and investigator considers that the patient is expected to have benefit such as antitumor effect, pain relief or improvement of performance state
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3])
C0184783 (UMLS CUI [4])
C1704632 (UMLS CUI [5,1])
C0442739 (UMLS CUI [5,2])
C1280500 (UMLS CUI [6,1])
C0521124 (UMLS CUI [6,2])
C0027651 (UMLS CUI [6,3])
C0451615 (UMLS CUI [7])
C1518965 (UMLS CUI [8,1])
C0184511 (UMLS CUI [8,2])
Toxicity CTCAE Grades | Toxicity hematologic CTCAE Grades
Item
patients who did not have grade >=3 non-hematologic toxicity or grade 4 hematologic toxicity during the preceding phase i/ii study or extension treatment of this study
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Investigational New Drug Benefit Expected | Effect Against Neoplasm | Pain relief | Performance status Improved
Item
investigator considers that the patient is expected to have benefit of this drug such as antitumor effect, pain relief or improvement of performance state.
boolean
C0013230 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C1280500 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0027651 (UMLS CUI [2,3])
C0451615 (UMLS CUI [3])
C1518965 (UMLS CUI [4,1])
C0184511 (UMLS CUI [4,2])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive | Blood product Requirement Check
Item
patient is known to be hbs antigen positive, hcv antibody positive or hiv antibody positive (check is required for patients who received blood product during phase i/ii study)
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
C0456388 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C1283174 (UMLS CUI [4,3])
Granulocyte Colony-Stimulating Factor | Blood Transfusion
Item
patients who receive g-csf product or blood transfusion within 7 days before the start of treatment
boolean
C0079459 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
Investigational New Drug Dose Recommended | Disease Progression
Item
disease progress was observed during the phase i/ii or this study when patients receive recommended dose
boolean
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0034866 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades | Neuropathic pain CTCAE Grades
Item
patients who suffer grade >=2 peripheral neuropathy or grade >=2 neuropathic pain
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C3714625 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Heart failure New York Heart Association Classification | Angina control - poor | Ventricular arrhythmia Uncontrolled Severe | Ischemia | Conduction system abnormalities
Item
patient has new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, acute ischemia or active conduction system abnormalities.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0421196 (UMLS CUI [2])
C0085612 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C0022116 (UMLS CUI [4])
C0151236 (UMLS CUI [5])