{"analyses":[{"ciLowerLimit":"0.39","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.95","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.74","paramType":"Odds Ratio (OR)","paramValue":"0.87","statisticalComment":"Adjusted for cancer type.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.41","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.88","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.87","paramType":"Odds Ratio (OR)","paramValue":"1.09","statisticalComment":"Adjusted for cancer type.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.44","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.57","groupDescription":"This is comparing the FN incidence rate in the arm randomized to alert against PP-CSF vs usual care in intermediate risk participants.","groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.68","paramType":"Odds Ratio (OR)","paramValue":"1.25","statisticalComment":"Adjusted for cancer type.","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.9"},{"groupId":"OG001","value":"2.9"},{"groupId":"OG002","value":"3.7"},{"groupId":"OG003","value":"3.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"202"},{"groupId":"OG001","value":"205"},{"groupId":"OG002","value":"540"},{"groupId":"OG003","value":"301"}],"units":"Participants"}],"description":"To compare the rate of FN among intermediate risk participants registered at intervention components by component treatment assignment (administer PP-CSF to intermediate risk participants versus not). Febrile neutropenia is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) as an absolute neutrophil count (ANC) \\< 1000/µL and a single temperature of \\> 38.3°C (101°F) or a sustained temperature of ≥ 38°C (101°F) for more than one hour.","groups":[{"description":"CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.","id":"OG000","title":"Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)"},{"description":"CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.","id":"OG001","title":"Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)"},{"description":"CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.","id":"OG002","title":"Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)"},{"description":"CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.","id":"OG003","title":"Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)"}],"paramType":"NUMBER","populationDescription":"The analysis population includes only participants that are classified as having intermediate risk of FN. Seven participants were deemed as having an unavailable outcome and were excluded from the analysis population.","reportingStatus":"POSTED","timeFrame":"Within 6 months post registration","title":"Incidence of Febrile Neutropenia Among Intermediate Risk Participants","type":"PRIMARY","unitOfMeasure":"percentage of participants"}