{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"5"}]}],"title":"Grade 3+ Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Grade 4+ Adverse Event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"102"}],"units":"Participants"}],"description":"Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.","groups":[{"description":"Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.","id":"OG000","title":"Baclofen-amitriptyline Hydrochloride-ketamine"},{"description":"Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All patients that were assessed for adverse events are used in this analysis.","reportingStatus":"POSTED","timeFrame":"Up to 4 weeks","title":"Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0","type":"SECONDARY","unitOfMeasure":"Participants"}