{"analyses":[{"ciNumSides":"TWO_SIDED","groupDescription":"Comparison between arms for Day 28 of treatment- FACIT-F total","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.559","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"ciNumSides":"TWO_SIDED","groupDescription":"Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F total","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"ciNumSides":"TWO_SIDED","groupDescription":"Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F total","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.192","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"ciNumSides":"TWO_SIDED","groupDescription":"Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F 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(n=18, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.6","value":"67.0"},{"groupId":"OG001","spread":"11.4","value":"68.9"}]}],"title":"FACIT-G-Day 1 (n=18, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.2","value":"49.0"},{"groupId":"OG001","spread":"15.3","value":"49.4"}]}],"title":"TOI-Day 1 (n=18, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.8","value":"86.2"},{"groupId":"OG001","spread":"20.4","value":"86.1"}]}],"title":"Total-Day 1 (n=19, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.6","value":"16.5"},{"groupId":"OG001","spread":"6.3","value":"17.4"}]}],"title":"PWB-Day 28 (n=19, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.3","value":"16.5"},{"groupId":"OG001","spread":"4.3","value":"18.7"}]}],"title":"EWB-Day 28 (n=19, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.5","value":"21.3"},{"groupId":"OG001","spread":"5.4","value":"20.8"}]}],"title":"SWB-Day 28 (n=19, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.1","value":"14.4"},{"groupId":"OG001","spread":"4.5","value":"16.8"}]}],"title":"FWB-Day 28 (n=19, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.22","value":"28.0"},{"groupId":"OG001","spread":"11.7","value":"26.5"}]}],"title":"Fatigue-Day 28 (n=19, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.5","value":"68.5"},{"groupId":"OG001","spread":"12.9","value":"75.8"}]}],"title":"FACIT-G-Day 28 (n=19, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.5","value":"59.4"},{"groupId":"OG001","spread":"18.7","value":"62.9"}]}],"title":"TOI-Day 28 (n=19, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.3","value":"96.5"},{"groupId":"OG001","spread":"21.9","value":"101.3"}]}],"title":"Total-Day 28 (n=19, 23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.1","value":"17.8"},{"comment":"Day 56 data was only evaluated for the Armodafinil arm","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"PWB-Day 56 (n=15)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.7","value":"22.1"},{"comment":"Day 56 data was only evaluated for the Armodafinil arm","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"EWB-Day 56 (n=15)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.4","value":"18.7"},{"comment":"Day 56 data was only evaluated for the Armodafinil arm","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"SWB-Day 56 (n=15)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.8","value":"13.5"},{"comment":"Day 56 data was only evaluated for the Armodafinil arm","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"FWB-Day 56 (n=15)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.2","value":"29.7"},{"comment":"Day 56 data was only evaluated for the Armodafinil arm","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"Fatigue-Day 56 (n=15)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.1","value":"73.2"},{"comment":"Day 56 data was only evaluated for the Armodafinil arm","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"FACIT-G-Day 56 (n=15)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.6","value":"62.7"},{"comment":"Day 56 data was only evaluated for the Armodafinil arm","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"TOI-Day 56 (n=15)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.7","value":"101.8"},{"comment":"Day 56 data was only evaluated for the Armodafinil arm","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"Total-Day 56 (n=15)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"description":"Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).","dispersionType":"Standard Deviation","groups":[{"description":"The patients receive armodafinil for all 56 days of the study.\n\nArmodafinil taken orally at 150 mg daily.","id":"OG000","title":"Armodafinil"},{"description":"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).\n\nPlacebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.","id":"OG001","title":"Placebo-First"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"Day 1, Day 28 and Day 56","title":"Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score","type":"SECONDARY","unitOfMeasure":"units on a scale"}