{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.96","value":"30.56"},{"groupId":"OG001","spread":"6.47","value":"30.56"},{"groupId":"OG002","spread":"2.79","value":"29.17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"391"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"title":"During Induction I (days 0 - 28 of therapy)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.69","value":"28.54"},{"groupId":"OG001","spread":"6.25","value":"28.52"},{"groupId":"OG002","spread":"4.83","value":"26.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"394"},{"groupId":"OG001","value":"405"},{"groupId":"OG002","value":"5"}],"units":"Participants"}],"title":"During Induction II (days 29 - 56 of therapy)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.95","value":"27.51"},{"groupId":"OG001","spread":"6.32","value":"28.10"},{"groupId":"OG002","spread":"3.70","value":"24.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"355"},{"groupId":"OG001","value":"383"},{"groupId":"OG002","value":"4"}],"units":"Participants"}],"title":"During Intensification I (days 57 - 84 of therapy)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"511"},{"groupId":"OG001","value":"511"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"description":"Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.","dispersionType":"Standard Deviation","groups":[{"description":"Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.","id":"OG000","title":"Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome"},{"description":"Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.","id":"OG001","title":"Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome"},{"description":"Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.","id":"OG002","title":"Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome"}],"paramType":"MEAN","populationDescription":"Excluded: Ineligible patients (pts) (n=42) for overall number of pts analyzed. For Induction I: Pts who did not have ANC recovery (n=237) or w/unknown (w/unk) status (n=14). For Induction II: Pts who did not have ANC recovery (n=142) or w/unk status (n=82). For Intensification I: Pts who did not have ANC recovery (n=104) or w/unk status (n=182)","reportingStatus":"POSTED","timeFrame":"At 25 days after treatment with Induction I, Induction II, and Intensification I","title":"Time to Marrow Recovery","type":"SECONDARY","unitOfMeasure":"Mean days"}