{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"12"},{"groupId":"OG004","value":"17"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"30"},{"groupId":"OG011","value":"27"},{"groupId":"OG012","value":"59"},{"groupId":"OG013","value":"65"},{"groupId":"OG014","value":"46"},{"groupId":"OG015","value":"47"},{"groupId":"OG016","value":"32"}]}],"title":"AEs (all causality)"},{"categories":[{"measurements":[{"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":"1"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"30"},{"groupId":"OG011","value":"27"},{"groupId":"OG012","value":"56"},{"groupId":"OG013","value":"61"},{"groupId":"OG014","value":"43"},{"groupId":"OG015","value":"45"},{"groupId":"OG016","value":"31"}]}],"title":"AEs (treatment-related)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"10"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"15"},{"groupId":"OG011","value":"11"},{"groupId":"OG012","value":"34"},{"groupId":"OG013","value":"31"},{"groupId":"OG014","value":"23"},{"groupId":"OG015","value":"21"},{"groupId":"OG016","value":"13"}]}],"title":"SAEs (all causality)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"8"},{"groupId":"OG013","value":"6"},{"groupId":"OG014","value":"6"},{"groupId":"OG015","value":"4"},{"groupId":"OG016","value":"1"}]}],"title":"SAEs (treatment-related)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"12"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"22"},{"groupId":"OG011","value":"22"},{"groupId":"OG012","value":"43"},{"groupId":"OG013","value":"50"},{"groupId":"OG014","value":"36"},{"groupId":"OG015","value":"36"},{"groupId":"OG016","value":"24"}]}],"title":"Grade 3 or 4 (all causality)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"13"},{"groupId":"OG011","value":"15"},{"groupId":"OG012","value":"31"},{"groupId":"OG013","value":"31"},{"groupId":"OG014","value":"22"},{"groupId":"OG015","value":"25"},{"groupId":"OG016","value":"16"}]}],"title":"Grade 3 or 4 (treatment-related)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"10"},{"groupId":"OG013","value":"11"},{"groupId":"OG014","value":"9"},{"groupId":"OG015","value":"7"},{"groupId":"OG016","value":"5"}]}],"title":"Grade 5 (all causality)"},{"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":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"},{"groupId":"OG013","value":"0"},{"groupId":"OG014","value":"0"},{"groupId":"OG015","value":"0"},{"groupId":"OG016","value":"0"}]}],"title":"Grade 5 (treatment-related)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"12"},{"groupId":"OG004","value":"17"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"30"},{"groupId":"OG011","value":"27"},{"groupId":"OG012","value":"60"},{"groupId":"OG013","value":"65"},{"groupId":"OG014","value":"46"},{"groupId":"OG015","value":"47"},{"groupId":"OG016","value":"32"}],"units":"Participants"}],"description":"AE: any untoward medical occurrence in clinical investigation participant administered a product or medical device, regardless of causal relationship to study treatment. Treatment-emergent AEs (TEAEs): AEs which occurred for first time during effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs): any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of ability to conduction normal life function). AEs included SAEs and non-serious AEs. Severity was graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.Grade1: mild, Grade2: moderate, Grade3: severe, Grade4: Life threatening consequences; urgent intervention indicated, Grade 5: death related to AE.","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)"},{"description":"Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) 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":"OG010","title":"EXP-1 (Phase 2)"},{"description":"Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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":"OG011","title":"EXP-2 (Phase 2)"},{"description":"Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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":"OG012","title":"EXP-3 (Phase 2)"},{"description":"Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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":"OG013","title":"EXP-4 (Phase 2)"},{"description":"Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) 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":"OG014","title":"EXP-5 (Phase 2)"},{"description":"Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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":"OG015","title":"EXP-6 (Phase 2)"},{"description":"Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.","id":"OG016","title":"DDI Sub-study"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.","reportingStatus":"POSTED","timeFrame":"From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)","title":"Number of Participants With Treatment-Emergent Adverse Events (Phase 1, Phase 2 and DDI Sub-study)","type":"SECONDARY","unitOfMeasure":"Participants"}