{"analyses":[{"groupDescription":"C1D8: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0000","paramType":"Least Squares Mean Difference","paramValue":"-1.2567","statisticalMethod":"ANCOVA"},{"groupDescription":"C2D1: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.8037","paramType":"Least Squares Mean Difference","paramValue":"0.1574","statisticalMethod":"ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.1","value":"-0.4"},{"groupId":"OG001","spread":"2.3","value":"1.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"73"}],"units":"Participants"}],"title":"Cycle 1 day 8 (C1D8)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.6","value":"0.0"},{"groupId":"OG001","spread":"2.8","value":"0.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"title":"Cycle 2 day 1 (C2D1)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"description":"The Brief Fatigue Inventory (BFI) was a screening tool designed to assess the severity and impact of fatigue on daily functioning of participants with cancer during the 24 hours. There are 9 items on the scale. The first three questions asked participants to rate their fatigues on a scale from 0 (no fatigue) - 10 (as bad as you can imagine), with higher scores indicating worse outcome. The remaining six questions asked participants to rate how much fatigue has interfered with their daily activities on a scale from 0 (Does not interfere) to 10 (Completely interferes). A global fatigue score can be obtained by averaging all the items on the BFI. The total score range is 0-10 with a higher BFI fatigue score indicates worse outcome. The global BFI score was calculated only if at least 5 of the 9 items are answered.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.","id":"OG000","title":"Gilteritinib"},{"description":"Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\\^2 daily by IV for 5 days, etoposide 100 mg/m\\^2 daily by IV for 5 days and cytarabine 1000 mg/m\\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).","id":"OG001","title":"Salvage Chemotherapy"}],"paramType":"MEAN","populationDescription":"The analysis population was the ITT, with participants with data at baseline.","reportingStatus":"POSTED","timeFrame":"Baseline, Cycle 1 Day 8 and Cycle 2 Day 1","title":"Change From Baseline in Brief Fatigue Inventory (BFI)","type":"SECONDARY","unitOfMeasure":"Units on a scale"}