{"classes":[{"categories":[{"measurements":[{"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":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"}]}],"title":"With DLT"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"2"}]}],"title":"No DLT"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"}]}],"title":"Data missing"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"16"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"3"}],"units":"Participants"}],"description":"DLT: any of following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for \\>7 days; febrile neutropenia; grade\\>=3 neutropenic infection; grade\\>=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade\\>=3 pancreatitis; grade\\>=3 toxicities (excluding grade \\>=3 laboratory abnormalities not requiring dose modifications) persisting after optimal treatment with standard medical therapy; symptomatic grade \\>=3 QT interval corrected for heart rate (QTc) prolongation, or asymptomatic grade \\>=3 prolongation that had been confirmed by repeat testing, re-evaluation by qualified person, persisted after correction of reversible causes; \\>=20% decrease from baseline in left ventricular ejection fraction (LVEF); (3) other: failure to deliver at least 16 out of 21 prescribed daily total dose due to toxicities attributable to study drug; failure to restart dosing after 21 days (1 cycle) delay due to toxicity attributable to study drug.","groups":[{"description":"PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.","id":"OG000","title":"10 mg QD (Phase 1)"},{"description":"PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.","id":"OG001","title":"25 mg QD (Phase 1)"},{"description":"PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.","id":"OG002","title":"50 mg QD (Phase 1)"},{"description":"PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.","id":"OG003","title":"75 mg QD (Phase 1)"},{"description":"PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.","id":"OG004","title":"100 mg QD (Phase 1)"},{"description":"PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.","id":"OG005","title":"150 mg QD (Phase 1)"},{"description":"PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.","id":"OG006","title":"200 mg QD (Phase 1)"},{"description":"PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.","id":"OG007","title":"35 mg BID (Phase 1)"},{"description":"PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.","id":"OG008","title":"75 mg BID (Phase 1)"},{"description":"PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.","id":"OG009","title":"100 mg BID (Phase 1)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Maximum Tolerated Dose (MTD) evaluable population included all enrolled participants who received at least 75% of the planned PF-06463922 doses in Cycle 1. Participants who received less than 75% of the planned PF-06463922 doses in Cycle 1 due to DLT were also considered evaluable for MTD. Here, \"Overall Number Analyzed\" signifies participants analyzed for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (21 days)","title":"Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1","type":"PRIMARY","unitOfMeasure":"Participants"}