{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"57.7","value":"40.3"},{"groupId":"OG001","spread":"52.1","value":"32.0"}]}],"title":"SPID5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"130.7","value":"115.0"},{"groupId":"OG001","spread":"108.0","value":"81.1"}]}],"title":"SPID10"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"209.7","value":"220.6"},{"groupId":"OG001","spread":"172.5","value":"150.3"}]}],"title":"SPID15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"731.9","value":"1122.0"},{"groupId":"OG001","spread":"614.5","value":"667.0"}]}],"title":"SPID45"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1016.2","value":"1649.0"},{"groupId":"OG001","spread":"862.1","value":"965.7"}]}],"title":"SPID60"}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"92"}],"units":"Participants"}],"description":"Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented \"no pain\" and 100 represented \"worst possible pain\" at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5\\*PID5), SPID10=(5\\*PID5)+(5\\*PID10), SPID15=(5\\*PID5)+(5\\*PID10)+(5\\*PID15), SPID30=(5\\*PID5)+(5\\*PID10)+(5\\*PID15)+(15\\*PID30), SPID45=(5\\*PID5)+(5\\*PID10)+(5\\*PID15)+(15\\*PID30)+(15\\*PID45), SPID60=(5\\*PID5)+(5\\*PID10)+(5\\*PID15)+(15\\*PID30) +(15\\*PID45) +(15\\*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.","id":"OG000","title":"Fentanyl Sublingual Spray"},{"description":"Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.","id":"OG001","title":"Placebo"}],"paramType":"MEAN","populationDescription":"Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.","reportingStatus":"POSTED","timeFrame":"Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode","title":"Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing","type":"SECONDARY","unitOfMeasure":"Units on a scale"}