{"protocolSection":{"identificationModule":{"nctId":"NCT03538743","orgStudyIdInfo":{"id":"C3421002"},"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes","officialTitle":"A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS"},"statusModule":{"statusVerifiedDate":"2020-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-06-25","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-05-23","type":"ACTUAL"},"completionDateStruct":{"date":"2019-06-10","type":"ACTUAL"},"studyFirstSubmitDate":"2018-05-07","studyFirstSubmitQcDate":"2018-05-24","studyFirstPostDateStruct":{"date":"2018-05-29","type":"ACTUAL"},"resultsFirstSubmitDate":"2020-05-08","resultsFirstSubmitQcDate":"2020-06-17","resultsFirstPostDateStruct":{"date":"2020-07-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-06-17","lastUpdatePostDateStruct":{"date":"2020-07-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"],"keywords":["Type 2 diabetes mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":98,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"PF-06882961 30 mg","type":"EXPERIMENTAL","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 100 mg","type":"EXPERIMENTAL","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 300 mg","type":"EXPERIMENTAL","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 600 mg","type":"EXPERIMENTAL","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 dose TBD Cohort 5","type":"EXPERIMENTAL","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 dose TBD Cohort 6","type":"EXPERIMENTAL","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 dose TBD Cohort 7","type":"EXPERIMENTAL","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 dose TBD Cohort 8","type":"EXPERIMENTAL","interventionNames":["Drug: PF-06882961"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"Tablet, 0 mg, twice daily, 28 days","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"PF-06882961","description":"Tablet, 15 mg twice daily, 28 days","armGroupLabels":["PF-06882961 30 mg"]},{"type":"DRUG","name":"PF-06882961","description":"Tablet, 50 mg twice daily, 28 days","armGroupLabels":["PF-06882961 100 mg"]},{"type":"DRUG","name":"PF-06882961","description":"Tablet, 150 mg twice daily, 28 days","armGroupLabels":["PF-06882961 300 mg"]},{"type":"DRUG","name":"PF-06882961","description":"Tablet, 300 mg twice daily, 28 days","armGroupLabels":["PF-06882961 600 mg"]},{"type":"DRUG","name":"PF-06882961","description":"Tablet, dose TBD, twice daily, Cohort 5, 28 days","armGroupLabels":["PF-06882961 dose TBD Cohort 5"]},{"type":"DRUG","name":"PF-06882961","description":"Tablet, dose TBD, twice daily, Cohort 6, 28 days","armGroupLabels":["PF-06882961 dose TBD Cohort 6"]},{"type":"DRUG","name":"PF-06882961","description":"Tablet, dose TBD, twice daily, Cohort 7, 28 days","armGroupLabels":["PF-06882961 dose TBD Cohort 7"]},{"type":"DRUG","name":"PF-06882961","description":"Tablet, dose TBD, twice daily, Cohort 8, 28 days","armGroupLabels":["PF-06882961 dose TBD Cohort 8"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)","description":"Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.","timeFrame":"From baseline to up to 35 days after last dose for a total of approximately 63 days"},{"measure":"Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality","description":"Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \\[PT\\], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).","timeFrame":"From baseline to up to 14 days after last dose for a total of approximately 42 days"},{"measure":"Number of Participants With Abnormal Vital Signs","description":"Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) \\<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \\<50 mmHg; 3) supine pulse rate \\<40 or \\>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (\\>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \\>= 20 mmHg.","timeFrame":"From baseline to up to 14 days after last dose for a total of approximately 42 days"},{"measure":"Number of Participants With Abnormal Electrocardiogram (ECG) Interval","description":"ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (\\>=) 300 millisecond (msec), b) \\>=25% increase when baseline is \\> 200 msec or \\>=50% increase when baseline is less than or equal to (\\<=) 200 msec.\n\n2\\. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) \\>=140 msec, b) \\>=50% increase from baseline.\n\n3\\. QTcF interval (QT corrected using the Fridericia formula): a) \\>450 msec and \\<=480 msec, b) \\>480 msec and \\<=500 msec, c) \\>500 msec, d) \\>30 msec and \\<=60 msec increase from baseline, e) \\>60 msec increase from baseline","timeFrame":"From baseline to up to 14 days after last dose for a total of approximately 42 days"}],"secondaryOutcomes":[{"measure":"AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28","description":"Area under the concentration-time profile from time zero to time 24 hours (AUC24) was calculated as AUCtau1 +AUCtau2, where AUCtau was area under the plasma concentration-time profile from time zero to time tau (tau1 = 0 to 10 hours and tau2=10 to 24 hours). AUCtau was determined using linear/log trapezoidal method.","timeFrame":"0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28"},{"measure":"Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28","description":"For BID dosing, parameters were calculated for both dosing intervals (0-10 hr = interval 1 and 10-24 hr = interval 2) and were displayed as Cmax1, Cmax2.\n\nCmax1: maximum plasma concentration during the dosing interval τ1 =0 to 10 hours.\n\nCmax2: maximum plasma concentration during the dosing interval τ2=10 to 24 hours.","timeFrame":"0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28"},{"measure":"Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28","description":"Time for Cmax, Cmax1 and Cmax2 (Tmax, Tmax1 and Tmax2) of PF-06293620 was observed directly from data as time of first occurrence.","timeFrame":"0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28"},{"measure":"Terminal Half-life (t½) of PF-06882961 on Day 28","description":"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.","timeFrame":"0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28"},{"measure":"Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28","description":"Ae was the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval was 24 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram \\[g\\]/1.020), where 1.020 g/mL was the approximate specific gravity of urine.","timeFrame":"0 to 24 hours post-dose on Day 28"},{"measure":"Ae24 (%) of PF-06882961 on Day 28","description":"Percent of dose recovered in urine as unchanged drug. Ae24% = 100\\* Ae24/Dose","timeFrame":"0 to 24 hours post-dose on Day 28"},{"measure":"Renal Clearance (CLr) of PF-06882961 on Day 28","description":"CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.","timeFrame":"0 to 24 hours post-dose on Day 28"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetes treated with a stable dose of metformin at least 500 mg\n* HbA1c value between 7.0 and 10.5%\n\nExclusion Criteria:\n\n\\- Type 1 diabetes or secondary forms of diabetes","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Anaheim Clinical Trials, LLC","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Qps-Mra, Llc","city":"South Miami","state":"Florida","zip":"33143","country":"United States","geoPoint":{"lat":25.7076,"lon":-80.29338}},{"facility":"Qps-Mra,Llc","city":"South Miami","state":"Florida","zip":"33143","country":"United States","geoPoint":{"lat":25.7076,"lon":-80.29338}},{"facility":"Altasciences Clinical Kansas, Inc.","city":"Overland Park","state":"Kansas","zip":"66212","country":"United States","geoPoint":{"lat":38.98223,"lon":-94.67079}}]},"referencesModule":{"references":[{"pmid":"34127852","type":"DERIVED","citation":"Saxena AR, Gorman DN, Esquejo RM, Bergman A, Chidsey K, Buckeridge C, Griffith DA, Kim AM. Danuglipron (PF-06882961) in type 2 diabetes: a randomized, placebo-controlled, multiple ascending-dose phase 1 trial. Nat Med. 2021 Jun;27(6):1079-1087. doi: 10.1038/s41591-021-01391-w. Epub 2021 Jun 14."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://pmiform.com/clinical-trial-info-request?StudyID=C3421002"}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally once daily (QD) or twice daily (BID) (dependent upon corresponding study treatment regimen) for a total of 28 days."},{"id":"FG001","title":"PF-06882961 10mg BID","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28."},{"id":"FG002","title":"PF-06882961 15mg BID","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days."},{"id":"FG003","title":"PF-06882961 50mg BID","description":"PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days."},{"id":"FG004","title":"PF-06882961 70mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days."},{"id":"FG005","title":"PF-06882961 120mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days."},{"id":"FG006","title":"PF-06882961 120mg BID Slow Titration (ST)","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days."},{"id":"FG007","title":"PF-06882961 120mg QD","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days."},{"id":"FG008","title":"PF-06882961 200mg QD Controlled Release (CR)","description":"PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"9"},{"groupId":"FG005","numSubjects":"9"},{"groupId":"FG006","numSubjects":"9"},{"groupId":"FG007","numSubjects":"8"},{"groupId":"FG008","numSubjects":"10"}]},{"type":"Received Treatment","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"9"},{"groupId":"FG005","numSubjects":"9"},{"groupId":"FG006","numSubjects":"9"},{"groupId":"FG007","numSubjects":"8"},{"groupId":"FG008","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"9"},{"groupId":"FG005","numSubjects":"9"},{"groupId":"FG006","numSubjects":"9"},{"groupId":"FG007","numSubjects":"8"},{"groupId":"FG008","numSubjects":"7"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}]},{"type":"Non-Treatment-Related Reasons","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants who received at least 1 dose of randomized study treatment.","groups":[{"id":"BG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days."},{"id":"BG001","title":"PF-06882961 10mg BID","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28."},{"id":"BG002","title":"PF-06882961 15mg BID","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days."},{"id":"BG003","title":"PF-06882961 50mg BID","description":"PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days."},{"id":"BG004","title":"PF-06882961 70mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days."},{"id":"BG005","title":"PF-06882961 120mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days."},{"id":"BG006","title":"PF-06882961 120mg BID ST","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days."},{"id":"BG007","title":"PF-06882961 120mg QD","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days."},{"id":"BG008","title":"PF-06882961 200mg QD CR","description":"PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days."},{"id":"BG009","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"9"},{"groupId":"BG005","value":"9"},{"groupId":"BG006","value":"9"},{"groupId":"BG007","value":"8"},{"groupId":"BG008","value":"10"},{"groupId":"BG009","value":"98"}]}],"measures":[{"title":"Age, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"18-44 years","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"4"}]},{"title":"45-64 years","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"8"},{"groupId":"BG005","value":"8"},{"groupId":"BG006","value":"7"},{"groupId":"BG007","value":"7"},{"groupId":"BG008","value":"8"},{"groupId":"BG009","value":"77"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"2"},{"groupId":"BG007","value":"1"},{"groupId":"BG008","value":"2"},{"groupId":"BG009","value":"17"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"2"},{"groupId":"BG006","value":"5"},{"groupId":"BG007","value":"4"},{"groupId":"BG008","value":"5"},{"groupId":"BG009","value":"47"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"7"},{"groupId":"BG006","value":"4"},{"groupId":"BG007","value":"4"},{"groupId":"BG008","value":"5"},{"groupId":"BG009","value":"51"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"6"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"4"},{"groupId":"BG007","value":"6"},{"groupId":"BG008","value":"6"},{"groupId":"BG009","value":"61"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"5"},{"groupId":"BG007","value":"2"},{"groupId":"BG008","value":"4"},{"groupId":"BG009","value":"37"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"4"},{"groupId":"BG007","value":"8"},{"groupId":"BG008","value":"7"},{"groupId":"BG009","value":"70"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"3"},{"groupId":"BG006","value":"5"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"27"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"1"}]}]}]},{"title":"Age Range","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"60.0","lowerLimit":"41","upperLimit":"70"},{"groupId":"BG001","value":"55.0","lowerLimit":"44","upperLimit":"61"},{"groupId":"BG002","value":"55.0","lowerLimit":"37","upperLimit":"68"},{"groupId":"BG003","value":"63.5","lowerLimit":"48","upperLimit":"68"},{"groupId":"BG004","value":"60.0","lowerLimit":"46","upperLimit":"65"},{"groupId":"BG005","value":"57.0","lowerLimit":"40","upperLimit":"64"},{"groupId":"BG006","value":"58.0","lowerLimit":"50","upperLimit":"69"},{"groupId":"BG007","value":"58.0","lowerLimit":"53","upperLimit":"66"},{"groupId":"BG008","value":"59.0","lowerLimit":"45","upperLimit":"69"},{"groupId":"BG009","value":"58.0","lowerLimit":"37","upperLimit":"70"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)","description":"Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.","populationDescription":"All randomized participants who received at least 1 dose of randomized study treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From baseline to up to 35 days after last dose for a total of approximately 63 days","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days."},{"id":"OG001","title":"PF-06882961 10mg BID","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28."},{"id":"OG002","title":"PF-06882961 15mg BID","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days."},{"id":"OG003","title":"PF-06882961 50mg BID","description":"PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days."},{"id":"OG004","title":"PF-06882961 70mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days."},{"id":"OG005","title":"PF-06882961 120mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days."},{"id":"OG006","title":"PF-06882961 120mg BID ST","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days."},{"id":"OG007","title":"PF-06882961 120mg QD","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days."},{"id":"OG008","title":"PF-06882961 200mg QD CR","description":"PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"8"},{"groupId":"OG008","value":"10"}]}],"classes":[{"title":"All-causality AE","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"8"},{"groupId":"OG008","value":"9"}]}]},{"title":"All-causality SAE","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"}]}]},{"title":"Treatment-related AE","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"8"},{"groupId":"OG008","value":"9"}]}]},{"title":"Treatment-related SAE","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"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality","description":"Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \\[PT\\], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).","populationDescription":"All randomized participants who received at least 1 dose of randomized study treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From baseline to up to 14 days after last dose for a total of approximately 42 days","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days."},{"id":"OG001","title":"PF-06882961 10mg BID","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28."},{"id":"OG002","title":"PF-06882961 15mg BID","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days."},{"id":"OG003","title":"PF-06882961 50mg BID","description":"PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days."},{"id":"OG004","title":"PF-06882961 70mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days."},{"id":"OG005","title":"PF-06882961 120mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days."},{"id":"OG006","title":"PF-06882961 120mg BID ST","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days."},{"id":"OG007","title":"PF-06882961 120mg QD","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days."},{"id":"OG008","title":"PF-06882961 200mg QD CR","description":"PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"8"},{"groupId":"OG008","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"10"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Abnormal Vital Signs","description":"Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) \\<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \\<50 mmHg; 3) supine pulse rate \\<40 or \\>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (\\>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \\>= 20 mmHg.","populationDescription":"All randomized participants who received at least 1 dose of randomized study treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From baseline to up to 14 days after last dose for a total of approximately 42 days","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days."},{"id":"OG001","title":"PF-06882961 10mg BID","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28."},{"id":"OG002","title":"PF-06882961 15mg BID","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days."},{"id":"OG003","title":"PF-06882961 50mg BID","description":"PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days."},{"id":"OG004","title":"PF-06882961 70mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days."},{"id":"OG005","title":"PF-06882961 120mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days."},{"id":"OG006","title":"PF-06882961 120mg BID ST","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days."},{"id":"OG007","title":"PF-06882961 120mg QD","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days."},{"id":"OG008","title":"PF-06882961 200mg QD CR","description":"PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"8"},{"groupId":"OG008","value":"10"}]}],"classes":[{"title":"Supine SBP <90 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"}]}]},{"title":"Supine SBP increase >=30 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"1"}]}]},{"title":"Supine SBP decrease >=30 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"4"}]}]},{"title":"Supine DBP <50 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]},{"title":"Supine DBP increase >=20 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"1"}]}]},{"title":"Supine DBP decrease >=20 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"3"}]}]},{"title":"Supine pulse rate <40 bpm","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"}]}]},{"title":"Supine pulse rate >120 bpm","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"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Abnormal Electrocardiogram (ECG) Interval","description":"ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (\\>=) 300 millisecond (msec), b) \\>=25% increase when baseline is \\> 200 msec or \\>=50% increase when baseline is less than or equal to (\\<=) 200 msec.\n\n2\\. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) \\>=140 msec, b) \\>=50% increase from baseline.\n\n3\\. QTcF interval (QT corrected using the Fridericia formula): a) \\>450 msec and \\<=480 msec, b) \\>480 msec and \\<=500 msec, c) \\>500 msec, d) \\>30 msec and \\<=60 msec increase from baseline, e) \\>60 msec increase from baseline","populationDescription":"All randomized participants who received at least 1 dose of randomized study treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From baseline to up to 14 days after last dose for a total of approximately 42 days","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days."},{"id":"OG001","title":"PF-06882961 10mg BID","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28."},{"id":"OG002","title":"PF-06882961 15mg BID","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days."},{"id":"OG003","title":"PF-06882961 50mg BID","description":"PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days."},{"id":"OG004","title":"PF-06882961 70mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days."},{"id":"OG005","title":"PF-06882961 120mg BID","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days."},{"id":"OG006","title":"PF-06882961 120mg BID ST","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days."},{"id":"OG007","title":"PF-06882961 120mg QD","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days."},{"id":"OG008","title":"PF-06882961 200mg QD CR","description":"PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"8"},{"groupId":"OG008","value":"10"}]}],"classes":[{"title":"PR interval ≥300 msec","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"}]}]},{"title":"%Change in PR interval ≥25/50%","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"}]}]},{"title":"QRS duration ≥140 msec","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"}]}]},{"title":"%Change in QRS duration ≥50%","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"}]}]},{"title":"QTcF interval >450 and ≤480 msec","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]},{"title":"QTcF interval >480 and ≤500 msec","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"}]}]},{"title":"QTcF interval >500 msec","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"}]}]},{"title":"Change in QTcF interval >30 and ≤60 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]},{"title":"Change in QTcF interval >60 msec","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"}]}]}]},{"type":"SECONDARY","title":"AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28","description":"Area under the concentration-time profile from time zero to time 24 hours (AUC24) was calculated as AUCtau1 +AUCtau2, where AUCtau was area under the plasma concentration-time profile from time zero to time tau (tau1 = 0 to 10 hours and tau2=10 to 24 hours). AUCtau was determined using linear/log trapezoidal method.","populationDescription":"All randomized participants who received at least 1 dose of PF-06882961 and who had at least 1 of the PK parameters of interest.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram.hours/milliliter (ng.h/mL)","timeFrame":"0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28","groups":[{"id":"OG000","title":"PF-06882961 15mg BID (Cohort 1)","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days."},{"id":"OG001","title":"PF-06882961 50mg BID (Cohort 2)","description":"PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days."},{"id":"OG002","title":"PF-06882961 70mg BID (Cohort 3)","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days."},{"id":"OG003","title":"PF-06882961 120mg BID (Cohort 4)","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days."},{"id":"OG004","title":"PF-06882961 10mg BID (Cohort 5)","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28."},{"id":"OG005","title":"PF-06882961 120mg BID ST (Cohort 6)","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days."},{"id":"OG006","title":"PF-06882961 200mg QD CR (Cohort 7)","description":"PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days."},{"id":"OG007","title":"PF-06882961 120mg QD (Cohort 8)","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"8"}]}],"classes":[{"title":"AUC24 on Day 1","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"8"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"707.5","spread":"43"},{"groupId":"OG001","value":"1502","spread":"29"},{"groupId":"OG002","value":"645.8","spread":"52"},{"groupId":"OG003","value":"666.1","spread":"54"},{"groupId":"OG004","value":"178.7","spread":"72"},{"groupId":"OG005","value":"324.0","spread":"41"},{"groupId":"OG006","value":"393.9","spread":"80"},{"groupId":"OG007","value":"184.6","spread":"49"}]}]},{"title":"AUCtau1 on Day 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dosing."},{"groupId":"OG007","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax only for QD dosing."}]}]},{"title":"Tmax2 on Day 14 or 21","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"8"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.0","lowerLimit":"12.0","upperLimit":"14.0"},{"groupId":"OG001","value":"13.0","lowerLimit":"10.0","upperLimit":"14.0"},{"groupId":"OG002","value":"12.0","lowerLimit":"12.0","upperLimit":"12.0"},{"groupId":"OG003","value":"12.0","lowerLimit":"10.0","upperLimit":"14.0"},{"groupId":"OG004","value":"12.0","lowerLimit":"12.0","upperLimit":"14.0"},{"groupId":"OG005","value":"14.0","lowerLimit":"12.0","upperLimit":"24.0"},{"groupId":"OG006","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax only for QD dosing."},{"groupId":"OG007","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax only for QD dosing."}]}]},{"title":"Tmax on Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"7"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax1 and Tmax2 only for BID dosing."},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax1 and Tmax2 only for BID dosing."},{"groupId":"OG002","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax1 and Tmax2 only for BID dosing."},{"groupId":"OG003","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax1 and Tmax2 only for BID dosing."},{"groupId":"OG004","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax1 and Tmax2 only for BID dosing."},{"groupId":"OG005","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax1 and Tmax2 only for BID dosing."},{"groupId":"OG006","value":"14.0","lowerLimit":"8.00","upperLimit":"14.0"},{"groupId":"OG007","value":"10.0","lowerLimit":"6.00","upperLimit":"14.0"}]}]},{"title":"Tmax1 on Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"7"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.00","lowerLimit":"4.00","upperLimit":"8.00"},{"groupId":"OG001","value":"3.00","lowerLimit":"0.00","upperLimit":"8.00"},{"groupId":"OG002","value":"6.00","lowerLimit":"2.00","upperLimit":"8.00"},{"groupId":"OG003","value":"4.00","lowerLimit":"1.00","upperLimit":"6.00"},{"groupId":"OG004","value":"4.00","lowerLimit":"2.00","upperLimit":"8.00"},{"groupId":"OG005","value":"6.00","lowerLimit":"4.00","upperLimit":"10.0"},{"groupId":"OG006","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax only for QD dosing."},{"groupId":"OG007","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax only for QD dosing."}]}]},{"title":"Tmax2 on Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"7"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"12.0","lowerLimit":"12.0","upperLimit":"14.0"},{"groupId":"OG001","value":"12.0","lowerLimit":"12.0","upperLimit":"12.0"},{"groupId":"OG002","value":"12.0","lowerLimit":"12.0","upperLimit":"14.0"},{"groupId":"OG003","value":"12.0","lowerLimit":"12.0","upperLimit":"14.0"},{"groupId":"OG004","value":"12.0","lowerLimit":"12.0","upperLimit":"14.0"},{"groupId":"OG005","value":"12.0","lowerLimit":"10.0","upperLimit":"14.0"},{"groupId":"OG006","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax only for QD dosing."},{"groupId":"OG007","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Data was calculated as Tmax only for QD dosing."}]}]}]},{"type":"SECONDARY","title":"Terminal Half-life (t½) of PF-06882961 on Day 28","description":"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.","populationDescription":"All participants randomized and treated who had at least 1 of the PK parameters of interest.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hours","timeFrame":"0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28","groups":[{"id":"OG000","title":"PF-06882961 15mg BID (Cohort 1)","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days."},{"id":"OG001","title":"PF-06882961 50mg BID (Cohort 2)","description":"PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days."},{"id":"OG002","title":"PF-06882961 70mg BID (Cohort 3)","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days."},{"id":"OG003","title":"PF-06882961 120mg BID (Cohort 4)","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days."},{"id":"OG004","title":"PF-06882961 10mg BID (Cohort 5)","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28."},{"id":"OG005","title":"PF-06882961 120mg BID ST (Cohort 6)","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days."},{"id":"OG006","title":"PF-06882961 200mg QD CR (Cohort 7)","description":"PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days."},{"id":"OG007","title":"PF-06882961 120mg QD (Cohort 8)","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.100","spread":"1.2186"},{"groupId":"OG001","value":"5.067","spread":"0.75593"},{"groupId":"OG002","value":"4.681","spread":"0.59504"},{"groupId":"OG003","value":"6.203","spread":"2.3505"},{"groupId":"OG004","value":"8.090","spread":"3.3234"},{"groupId":"OG005","value":"6.730","spread":"2.5056"},{"groupId":"OG006","value":"5.773","spread":"1.4876"},{"groupId":"OG007","value":"4.954","spread":"0.58819"}]}]}]},{"type":"SECONDARY","title":"Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28","description":"Ae was the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval was 24 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. 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There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated."},{"groupId":"OG004","value":"14.97","spread":"67"},{"groupId":"OG005","value":"62.63","spread":"439"},{"groupId":"OG006","value":"72.98","spread":"38"},{"groupId":"OG007","value":"49.09","spread":"97"}]}]}]},{"type":"SECONDARY","title":"Ae24 (%) of PF-06882961 on Day 28","description":"Percent of dose recovered in urine as unchanged drug. Ae24% = 100\\* Ae24/Dose","populationDescription":"All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Percentage","timeFrame":"0 to 24 hours post-dose on Day 28","groups":[{"id":"OG000","title":"PF-06882961 15mg BID (Cohort 1)","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days."},{"id":"OG001","title":"PF-06882961 50mg BID (Cohort 2)","description":"PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days."},{"id":"OG002","title":"PF-06882961 70mg BID (Cohort 3)","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days."},{"id":"OG003","title":"PF-06882961 120mg BID (Cohort 4)","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days."},{"id":"OG004","title":"PF-06882961 10mg BID (Cohort 5)","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28."},{"id":"OG005","title":"PF-06882961 120mg BID ST (Cohort 6)","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days."},{"id":"OG006","title":"PF-06882961 200mg QD CR (Cohort 7)","description":"PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days."},{"id":"OG007","title":"PF-06882961 120mg QD (Cohort 8)","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.05747","spread":"36"},{"groupId":"OG001","value":"0.03360","spread":"69"},{"groupId":"OG002","value":"0.02942","spread":"242"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"\"NA\" indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated."},{"groupId":"OG004","value":"0.07483","spread":"67"},{"groupId":"OG005","value":"0.02607","spread":"439"},{"groupId":"OG006","value":"0.03652","spread":"38"},{"groupId":"OG007","value":"0.04094","spread":"97"}]}]}]},{"type":"SECONDARY","title":"Renal Clearance (CLr) of PF-06882961 on Day 28","description":"CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.","populationDescription":"All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"mL/min","timeFrame":"0 to 24 hours post-dose on Day 28","groups":[{"id":"OG000","title":"PF-06882961 15mg BID (Cohort 1)","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days."},{"id":"OG001","title":"PF-06882961 50mg BID (Cohort 2)","description":"PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days."},{"id":"OG002","title":"PF-06882961 70mg BID (Cohort 3)","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days."},{"id":"OG003","title":"PF-06882961 120mg BID (Cohort 4)","description":"PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days."},{"id":"OG004","title":"PF-06882961 10mg BID (Cohort 5)","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28."},{"id":"OG005","title":"PF-06882961 120mg BID ST (Cohort 6)","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days."},{"id":"OG006","title":"PF-06882961 200mg QD CR (Cohort 7)","description":"PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days."},{"id":"OG007","title":"PF-06882961 120mg QD (Cohort 8)","description":"PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.3273","spread":"18"},{"groupId":"OG001","value":"0.3385","spread":"18"},{"groupId":"OG002","value":"0.3094","spread":"70"},{"groupId":"OG003","value":"NA","spread":"NA","comment":"\"NA\" indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated."},{"groupId":"OG004","value":"0.5470","spread":"26"},{"groupId":"OG005","value":"0.2006","spread":"228"},{"groupId":"OG006","value":"0.2895","spread":"21"},{"groupId":"OG007","value":"0.3178","spread":"73"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline up to 35 days after last dose for a total of approximately 63 days","description":"The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.","deathsNumAffected":0,"deathsNumAtRisk":25,"seriousNumAffected":0,"seriousNumAtRisk":25,"otherNumAffected":15,"otherNumAtRisk":25},{"id":"EG001","title":"PF-06882961 10mg BID","description":"PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.","deathsNumAffected":0,"deathsNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"otherNumAffected":6,"otherNumAtRisk":9},{"id":"EG002","title":"PF-06882961 15mg BID","description":"PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 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treatment-related.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":25},{"groupId":"EG001","numAffected":0,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":9},{"groupId":"EG006","numAffected":1,"numAtRisk":9},{"groupId":"EG007","numAffected":0,"numAtRisk":8},{"groupId":"EG008","numAffected":0,"numAtRisk":10}]}],"otherEvents":[{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v22.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":25},{"groupId":"EG001","numAffected":1,"numAtRisk":9},{"groupId":"EG002","numAffected":0,"numAtRisk":9},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":9},{"groupId":"EG006","numAffected":0,"numAtRisk":9},{"groupId":"EG007","numAffected":0,"numAtRisk":8},{"groupId":"EG008","numAffected":0,"numAtRisk":10}]},{"term":"Ear discomfort","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 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