{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"30"}]}],"title":"Responses according to IWG MDS Criteria"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"Responses according to IWG AML Criteria"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Responses according to Both Criteria"}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"}],"units":"Participants"}],"description":"The null hypothesis to be tested was the percentage who will respond to combination arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) therapy is \\<10%. A total of \\>/= 9 responses observed in 30 evaluable patients was taken as evidence warranting further study of the regimen, provided the toxicity profile also appears favorable. The IWG Criteria standardizes the clinical responses in MDS and AML based upon hematologic improvement, quality of life and cytogenic improvement. These standardizations allow for the responses to be determined as either complete responses or partial responses.","groups":[{"description":"Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m\\^2 D8 for 1 or 2 Cycles of 12 Weeks each\n\narsenic trioxide: Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12).\n\ngemtuzumab ozogamicin: Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion","id":"OG000","title":"ATO + GO"}],"paramType":"NUMBER","populationDescription":"Responses According to IWG MDS Criteria (n=30) Responses According to IWG AML Criteria (n=12)","reportingStatus":"POSTED","timeFrame":"at 12 weeks post treatment","title":"Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)","type":"PRIMARY","unitOfMeasure":"percentage of patients"}