{"analyses":[{"ciLowerLimit":"0.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.95","groupDescription":"FN incidence rate in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).","groupIds":["OG001","OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.26","paramType":"Odds Ratio (OR)","paramValue":"1.49","statisticalComment":"Adjusted for age.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.23","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"18.80","groupDescription":"FN incidence rate in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).","groupIds":["OG001","OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.51","paramType":"Odds Ratio (OR)","paramValue":"2.00","statisticalComment":"Adjusted for cancer type.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.41","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.88","groupDescription":"FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.87","paramType":"Odds Ratio (OR)","paramValue":"1.09","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.44","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.57","groupDescription":"FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).","groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.68","paramType":"Odds Ratio (OR)","paramValue":"1.25","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.7"},{"groupId":"OG001","value":"0.8"},{"groupId":"OG002","value":"1.6"},{"groupId":"OG003","value":"1.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"127"},{"groupId":"OG002","value":"245"},{"groupId":"OG003","value":"207"}],"units":"Participants"}],"title":"Low Risk Group"},{"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"}],"title":"Intermediate Risk Group"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6.5"},{"groupId":"OG001","value":"4.2"},{"groupId":"OG002","value":"5.7"},{"groupId":"OG003","value":"6.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"384"},{"groupId":"OG001","value":"308"},{"groupId":"OG002","value":"490"},{"groupId":"OG003","value":"457"}],"units":"Participants"}],"title":"High Risk Group"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5.5"},{"groupId":"OG001","value":"3.1"},{"groupId":"OG002","value":"4.1"},{"groupId":"OG003","value":"4.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"707"},{"groupId":"OG001","value":"640"},{"groupId":"OG002","value":"1275"},{"groupId":"OG003","value":"965"}],"units":"Participants"}],"title":"All FN Risk Groups"}],"denoms":[{"counts":[{"groupId":"OG000","value":"707"},{"groupId":"OG001","value":"640"},{"groupId":"OG002","value":"1275"},{"groupId":"OG003","value":"965"}],"units":"Participants"}],"description":"To compare the rate of febrile neutropenia (FN) among participants, at any risk level, registered at intervention components versus usual care components. 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":"There were 18 participants deemed as having an unavailable outcome and were excluded from the analysis population, leaving 3587 analyzable participants.","reportingStatus":"POSTED","timeFrame":"Within 6 months post registration","title":"Incidence of Febrile Neutropenia","type":"PRIMARY","unitOfMeasure":"percentage of participants"}