{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"46.9","value":"8.99"},{"groupId":"OG001","spread":"26.0","value":"3.72"},{"groupId":"OG002","spread":"18.3","value":"4.42"},{"groupId":"OG003","spread":"9.88","value":"3.91"},{"groupId":"OG004","spread":"50.2","value":"4.14"},{"groupId":"OG005","spread":"32.1","value":"4.48"},{"groupId":"OG006","spread":"85.6","value":"5.78"},{"groupId":"OG007","spread":"66.0","value":"4.92"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"}],"units":"Participants"}],"title":"RA, AUC0-24: Day 21"},{"categories":[{"measurements":[{"groupId":"OG008","spread":"33.9","value":"6.14"},{"groupId":"OG009","spread":"42.9","value":"5.81"},{"groupId":"OG010","spread":"36.9","value":"3.40"},{"groupId":"OG011","spread":"85.5","value":"9.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"15"}],"units":"Participants"}],"title":"RA, AUC0-24: Day 28"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"49.1","value":"8.26"},{"groupId":"OG001","spread":"33.7","value":"3.08"},{"groupId":"OG002","spread":"42.5","value":"3.74"},{"groupId":"OG003","spread":"38.4","value":"3.54"},{"groupId":"OG004","spread":"69.4","value":"2.86"},{"groupId":"OG005","spread":"59.3","value":"3.07"},{"groupId":"OG006","spread":"52.5","value":"2.73"},{"groupId":"OG007","spread":"69.0","value":"4.06"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"}],"units":"Participants"}],"title":"RA, Cmax: Day 21"},{"categories":[{"measurements":[{"groupId":"OG008","spread":"44.4","value":"6.19"},{"groupId":"OG009","spread":"55.3","value":"3.75"},{"groupId":"OG010","spread":"29.6","value":"2.59"},{"groupId":"OG011","spread":"70.7","value":"2.13"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"15"}],"units":"Participants"}],"title":"RA, Cmax: Day 28"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"15"}],"units":"Participants"}],"description":"Plasma samples were collected and used for pharmacokinetics assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%).","dispersionType":"Standard Deviation","groups":[{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.","id":"OG000","title":"Phase 1, Schedule A: 20 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG001","title":"Phase 1, Schedule A: 40 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG002","title":"Phase 1, Schedule A: 80 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG003","title":"Phase 1, Schedule A: 120 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG004","title":"Phase 1, Schedule A: 180 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG005","title":"Phase 1, Schedule A: 270 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG006","title":"Phase 1, Schedule A: 300 mg"},{"description":"All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle","id":"OG007","title":"Phase 1, Schedule A: 360 mg"},{"description":"All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.","id":"OG008","title":"Phase 1, Schedule B: 120 mg"},{"description":"All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.","id":"OG009","title":"Phase 1, Schedule B: 180 mg"},{"description":"All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle","id":"OG010","title":"Phase 1, Schedule B: 250 mg"},{"description":"Participants who had failed standard of care including Venetoclax and Gilteritining based therapies.\n\nNMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards","id":"OG011","title":"Phase 2, Schedule B:360+150 mg"}],"paramType":"MEAN","populationDescription":"Participants evaluable for PK analysis (treated participants were considered evaluable if they had sufficient baseline and on-study sampled material to provide interpretable results). The plasma PK of NMS-03592088 and 2 metabolites NMS-03593860 and NMS-03603422 were collected, and PK profile characterised.\n\nSchedule A: Day 21 Schedule B: Day 28 Evaluation of Accumulation ratios (RA) for AUC0-24 and Cmax on Day 1 of all arms in Schedule A and Schedule B has not been performed.","reportingStatus":"POSTED","timeFrame":"Schedule A: Day 21 Schedule B: Day 28 Evaluation of Accumulation ratios (RA) for AUC0-24 and Cmax on Day 1 of all arms in Schedule A and Schedule B has not been performed.","title":"Pharmacokinetic Parameters: Accumulation Ratios (RA) for AUC0-24 and Cmax","type":"SECONDARY","unitOfMeasure":"Ratio"}