{"protocolSection":{"identificationModule":{"nctId":"NCT03985293","orgStudyIdInfo":{"id":"C3421005"},"secondaryIdInfos":[{"id":"2019-000218-12","type":"EUDRACT_NUMBER"},{"id":"2019","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2019"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus","officialTitle":"A 16-WEEK, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWICE DAILY PF-06882961 ADMINISTRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON METFORMIN OR DIET AND EXERCISE"},"statusModule":{"statusVerifiedDate":"2022-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-10-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-06-08","type":"ACTUAL"},"completionDateStruct":{"date":"2021-07-07","type":"ACTUAL"},"studyFirstSubmitDate":"2019-06-11","studyFirstSubmitQcDate":"2019-06-11","studyFirstPostDateStruct":{"date":"2019-06-13","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-06-02","resultsFirstSubmitQcDate":"2022-06-02","resultsFirstPostDateStruct":{"date":"2022-06-30","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-06-02","lastUpdatePostDateStruct":{"date":"2022-06-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":412,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"PF-06882961 2.5 milligrams (mg)","type":"EXPERIMENTAL","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 10 mg","type":"EXPERIMENTAL","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 40 mg","type":"EXPERIMENTAL","description":"Participants will be titrated up to 2 weeks to reach desired dose level","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 80 mg","type":"EXPERIMENTAL","description":"Participants will be titrated up to 4 weeks to reach desired dose level","interventionNames":["Drug: PF-06882961"]},{"label":"PF-06882961 120 mg","type":"EXPERIMENTAL","description":"Participants will be titrated up to 6 weeks to reach desired dose level","interventionNames":["Drug: PF-06882961"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"4 matching placebo tablets taken twice a day (BID)","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"PF-06882961","description":"Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 weeks.","armGroupLabels":["PF-06882961 10 mg","PF-06882961 120 mg","PF-06882961 2.5 milligrams (mg)","PF-06882961 40 mg","PF-06882961 80 mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16","description":"HbA1c can be used as a diagnostic test for diabetes. 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The target HbA1c level for people with diabetes is usually less than 7%.","timeFrame":"Baseline, Week 4"},{"measure":"Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6","description":"HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.","timeFrame":"Baseline, Week 6"},{"measure":"Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8","description":"HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.","timeFrame":"Baseline, Week 8"},{"measure":"Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12","description":"HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.","timeFrame":"Baseline, Week 12"},{"measure":"Change From Baseline in Fasting Plasma Glucose at Week 2","description":"The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 milligram per deciliter (mg/dL) to 99 mg/dL.","timeFrame":"Baseline, Week 2"},{"measure":"Change From Baseline in Fasting Plasma Glucose at Week 4","description":"The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.","timeFrame":"Baseline, Week 4"},{"measure":"Change From Baseline in Fasting Plasma Glucose at Week 6","description":"The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.","timeFrame":"Baseline, Week 6"},{"measure":"Change From Baseline in Fasting Plasma Glucose at Week 8","description":"The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.","timeFrame":"Baseline, Week 8"},{"measure":"Change From Baseline in Fasting Plasma Glucose at Week 12","description":"The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.","timeFrame":"Baseline, Week 12"},{"measure":"Change From Baseline in Fasting Plasma Glucose at Week 16","description":"The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.","timeFrame":"Baseline, Week 16"},{"measure":"Change From Baseline in Body Weight at Week 2","description":"Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.","timeFrame":"Baseline, Week 2"},{"measure":"Change From Baseline in Body Weight at Week 4","description":"Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.","timeFrame":"Baseline, Week 4"},{"measure":"Change From Baseline in Body Weight at Week 6","description":"Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.","timeFrame":"Baseline, Week 6"},{"measure":"Change From Baseline in Body Weight at Week 8","description":"Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.","timeFrame":"Baseline, Week 8"},{"measure":"Change From Baseline in Body Weight at Week 12","description":"Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.","timeFrame":"Baseline, Week 12"},{"measure":"Change From Baseline in Body Weight at Week 16","description":"Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.","timeFrame":"Baseline, Week 16"},{"measure":"Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])","description":"An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the 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. 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Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314493. doi: 10.1001/jamanetworkopen.2023.14493."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://pmiform.com/clinical-trial-info-request?StudyID=C3421005"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","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.","url":"https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 859 participants were screened in the study, among whom, 412 participants were randomized, and 411 participants were treated with PF-06882961 (Danuglipron)/placebo; 1 participant randomized to the PF-06882961 120 mg BID group was not treated.","groups":[{"id":"FG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"FG001","title":"PF-06882961 2.5mg BID","description":"PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"FG002","title":"PF-06882961 10mg BID","description":"PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"FG003","title":"PF-06882961 40mg BID","description":"PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. 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Titration was implemented."},{"id":"OG004","title":"PF-06882961 80 mg BID","description":"PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."},{"id":"OG005","title":"PF-06882961 120 mg BID","description":"PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. 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Titration was implemented."},{"id":"OG004","title":"PF-06882961 80 mg BID","description":"PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."},{"id":"OG005","title":"PF-06882961 120 mg BID","description":"PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"57"},{"groupId":"OG004","value":"46"},{"groupId":"OG005","value":"38"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.43","lowerLimit":"-1.12","upperLimit":"0.25"},{"groupId":"OG001","value":"0.02","lowerLimit":"-0.68","upperLimit":"0.72"},{"groupId":"OG002","value":"-0.06","lowerLimit":"-0.71","upperLimit":"0.60"},{"groupId":"OG003","value":"-1.16","lowerLimit":"-1.84","upperLimit":"-0.49"},{"groupId":"OG004","value":"-2.48","lowerLimit":"-3.20","upperLimit":"-1.75"},{"groupId":"OG005","value":"-4.60","lowerLimit":"-5.34","upperLimit":"-3.86"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4325","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)","paramType":"Difference in LS Mean","paramValue":"0.45","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"1.41","estimateComment":"PF-06882961 = Test Placebo = Reference"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4978","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)","paramType":"Difference in LS Mean","paramValue":"0.38","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.54","ciUpperLimit":"1.30","estimateComment":"PF-06882961 = Test Placebo = Reference"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1970","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)","paramType":"Difference in LS Mean","paramValue":"-0.73","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.66","ciUpperLimit":"0.20","estimateComment":"PF-06882961 = Test Placebo = Reference"},{"groupIds":["OG000","OG004"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0006","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)","paramType":"Difference in LS Mean","paramValue":"-2.04","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.01","ciUpperLimit":"-1.07","estimateComment":"PF-06882961 = Test Placebo = Reference"},{"groupIds":["OG000","OG005"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)","paramType":"Difference in LS Mean","paramValue":"-4.17","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.15","ciUpperLimit":"-3.18","estimateComment":"PF-06882961 = Test Placebo = Reference"}]},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])","description":"An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the 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":"Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline up to Week 21","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG001","title":"PF-06882961 2.5 BID","description":"PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG002","title":"PF-06882961 10 mg BID","description":"PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG003","title":"PF-06882961 40 mg BID","description":"PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."},{"id":"OG004","title":"PF-06882961 80 mg BID","description":"PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."},{"id":"OG005","title":"PF-06882961 120 mg BID","description":"PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"71"},{"groupId":"OG004","value":"67"},{"groupId":"OG005","value":"71"}]}],"classes":[{"title":"Number of Participants With Treatment Emergent AEs","categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"31"},{"groupId":"OG003","value":"42"},{"groupId":"OG004","value":"43"},{"groupId":"OG005","value":"44"}]}]},{"title":"Number of Participants With Treatment Emergent SAEs","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Clinical 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/INR, 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); lipid panel (low density lipoprotein cholesterol, high density lipoprotein cholesterol).","populationDescription":"Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 measurement available.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline Through Week 21","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG001","title":"PF-06882961 2.5 BID","description":"PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG002","title":"PF-06882961 10 mg BID","description":"PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG003","title":"PF-06882961 40 mg BID","description":"PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. 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Titration was implemented."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"71"},{"groupId":"OG004","value":"67"},{"groupId":"OG005","value":"71"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"57"},{"groupId":"OG004","value":"60"},{"groupId":"OG005","value":"64"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Vital Signs Abnormalities","description":"Vital signs abnormality 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":"Overall number of participants analyzed included all participants randomly assigned to study treatment, took at least 1 dose of study treatment and had at least 1 measurement available.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline through Week 21","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG001","title":"PF-06882961 2.5 BID","description":"PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG002","title":"PF-06882961 10 mg BID","description":"PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG003","title":"PF-06882961 40 mg BID","description":"PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."},{"id":"OG004","title":"PF-06882961 80 mg BID","description":"PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."},{"id":"OG005","title":"PF-06882961 120 mg BID","description":"PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"71"},{"groupId":"OG004","value":"67"},{"groupId":"OG005","value":"71"}]}],"classes":[{"title":"Supine SBP <90 mmHg","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"}]}]},{"title":"Supine SBP increase >=30 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"5"}]}]},{"title":"Supine SBP decrease >=30 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"0"}]}]},{"title":"Supine DBP <50 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"}]}]},{"title":"Supine DBP increase >=20 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"}]}]},{"title":"Supine DBP decrease >=20 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"1"}]}]},{"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"}]}]},{"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"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent ECG Abnormalities","description":"ECG categorical abnormality 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 interval (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":"Overall number of participants analyzed included all participants randomly assigned to study treatment, took at least 1 dose of study treatment and had at least 1 measurement available.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline Through Week 21","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG001","title":"PF-06882961 2.5 BID","description":"PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG002","title":"PF-06882961 10 mg BID","description":"PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up."},{"id":"OG003","title":"PF-06882961 40 mg BID","description":"PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."},{"id":"OG004","title":"PF-06882961 80 mg BID","description":"PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."},{"id":"OG005","title":"PF-06882961 120 mg BID","description":"PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"71"},{"groupId":"OG004","value":"67"},{"groupId":"OG005","value":"71"}]}],"classes":[{"title":"PR interval ≥300 msec","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"71"},{"groupId":"OG004","value":"67"},{"groupId":"OG005","value":"71"}]}],"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":"1"}]}]},{"title":"%Change in PR interval 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Titration was implemented.","deathsNumAffected":2,"deathsNumAtRisk":71,"seriousNumAffected":6,"seriousNumAtRisk":71,"otherNumAffected":33,"otherNumAtRisk":71},{"id":"EG004","title":"PF-06882961 80mg BID","description":"PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.","deathsNumAffected":0,"deathsNumAtRisk":67,"seriousNumAffected":2,"seriousNumAtRisk":67,"otherNumAffected":40,"otherNumAtRisk":67},{"id":"EG005","title":"PF-06882961 120mg BID","description":"PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. 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v24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":66},{"groupId":"EG001","numAffected":0,"numAtRisk":68},{"groupId":"EG002","numAffected":0,"numAtRisk":68},{"groupId":"EG003","numAffected":0,"numAtRisk":71},{"groupId":"EG004","numAffected":0,"numAtRisk":67},{"groupId":"EG005","numAffected":0,"numAtRisk":71}]},{"term":"Seroma","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":66},{"groupId":"EG001","numAffected":0,"numAtRisk":68},{"groupId":"EG002","numAffected":0,"numAtRisk":68},{"groupId":"EG003","numAffected":1,"numAtRisk":71},{"groupId":"EG004","numAffected":0,"numAtRisk":67},{"groupId":"EG005","numAffected":0,"numAtRisk":71}]},{"term":"Gamma-glutamyltransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 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