{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.4","upperLimit":"3.2","value":"2.32"}]}],"title":"C1D1: Pain Severity (n=26)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.7","upperLimit":"3.6","value":"2.62"}]}],"title":"C1D8: Pain Severity (n=25)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.5","upperLimit":"3.4","value":"2.44"}]}],"title":"C1D15: Pain Severity (n=24)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.5","upperLimit":"3.2","value":"2.30"}]}],"title":"C2D1: Pain Severity (n=24)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.2","upperLimit":"3.1","value":"2.12"}]}],"title":"C3D1: Pain Severity (n=21)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.9","upperLimit":"3.1","value":"2.02"}]}],"title":"C4D1: Pain Severity (n=17)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.0","upperLimit":"3.4","value":"2.22"}]}],"title":"C5D1: Pain Severity (n=16)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.7","upperLimit":"2.6","value":"1.66"}]}],"title":"C6D1: Pain Severity (n=14)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.5","upperLimit":"3.5","value":"1.98"}]}],"title":"C7D1: Pain Severity (n=10)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.6","upperLimit":"4.4","value":"2.47"}]}],"title":"C8D1: Pain Severity (n=9)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.5","upperLimit":"3.1","value":"1.81"}]}],"title":"C9D1: Pain Severity (n=9)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.1","upperLimit":"2.3","value":"1.08"}]}],"title":"C10D1: Pain Severity (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.0","upperLimit":"2.9","value":"1.45"}]}],"title":"C11D1: Pain Severity (n=5)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.4","upperLimit":"2.9","value":"1.67"}]}],"title":"C12D1: Pain Severity (n=5)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.1","upperLimit":"1.7","value":"0.93"}]}],"title":"C13D1: Pain Severity (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.1","upperLimit":"2.7","value":"1.42"}]}],"title":"C14D1: Pain Severity (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.0","upperLimit":"2.1","value":"1.04"}]}],"title":"C15D1: Pain Severity (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"2.9","value":"1.46"}]}],"title":"C16D1: Pain Severity (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.3","upperLimit":"3.6","value":"1.67"}]}],"title":"C17D1: Pain Severity (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.1","upperLimit":"4.7","value":"2.88"}]}],"title":"C18D1: Pain Severity (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.3","upperLimit":"6.1","value":"3.69"}]}],"title":"C19D1: Pain Severity (n=4)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.3","upperLimit":"6.7","value":"3.50"}]}],"title":"C20D1: Pain Severity (n=2)"},{"categories":[{"measurements":[{"comment":"95% CI was not estimable since only 1 participant was evaluable.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"4.00"}]}],"title":"C21D1: Pain Severity (n=1)"},{"categories":[{"measurements":[{"comment":"95% CI was not estimable since only 1 participant was evaluable.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"4.50"}]}],"title":"C22D1: Pain Severity (n=1)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"4.6","value":"3.30"}]}],"title":"End of Treatment: Pain Severity (n=16)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.4","upperLimit":"3.6","value":"2.53"}]}],"title":"C1D1: Pain Interference (n=25)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.4","upperLimit":"3.7","value":"2.58"}]}],"title":"C1D8: Pain Interference (n=25)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"4.3","value":"3.06"}]}],"title":"C1D15: Pain Interference (n=23)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.5","upperLimit":"3.7","value":"2.64"}]}],"title":"C2D1: Pain Interference (n=23)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.1","upperLimit":"3.5","value":"2.34"}]}],"title":"C3D1: Pain Interference (n=21)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.2","upperLimit":"3.9","value":"2.54"}]}],"title":"C4D1: Pain Interference (n=17)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.3","upperLimit":"4.2","value":"2.74"}]}],"title":"C5D1: Pain Interference (n=16)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.8","upperLimit":"3.7","value":"2.26"}]}],"title":"C6D1: Pain Interference (n=14)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.6","upperLimit":"5.3","value":"2.94"}]}],"title":"C7D1: Pain Interference (n=10)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.6","upperLimit":"4.6","value":"2.60"}]}],"title":"C8D1: Pain Interference (n=9)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.0","upperLimit":"4.3","value":"2.13"}]}],"title":"C9D1: Pain Interference (n=9)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.1","upperLimit":"4.2","value":"2.07"}]}],"title":"C10D1: Pain Interference (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.1","upperLimit":"3.7","value":"2.40"}]}],"title":"C11D1: Pain Interference (n=5)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.0","upperLimit":"4.8","value":"2.91"}]}],"title":"C12D1: Pain Interference (n=5)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.3","upperLimit":"3.5","value":"1.90"}]}],"title":"C13D1: Pain Interference (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.1","upperLimit":"2.1","value":"0.98"}]}],"title":"C14D1: Pain Interference (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.2","upperLimit":"2.4","value":"1.31"}]}],"title":"C15D1: Pain Interference (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.4","upperLimit":"3.3","value":"1.83"}]}],"title":"C16D1: Pain Interference (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.4","upperLimit":"2.6","value":"1.50"}]}],"title":"C17D1: Pain Interference (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.9","upperLimit":"4.9","value":"2.86"}]}],"title":"C18D1: Pain Interference (n=6)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"6.0","value":"4.07"}]}],"title":"C19D1: Pain Interference (n=4)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-14.0","upperLimit":"24.1","value":"5.07"}]}],"title":"C20D1: Pain Interference (n=2)"},{"categories":[{"measurements":[{"comment":"95% CI was not estimable since only 1 participant was evaluable.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"2.57"}]}],"title":"C21D1: Pain Interference (n=1)"},{"categories":[{"measurements":[{"comment":"95% CI was not estimable since only 1 participant was evaluable.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"6.71"}]}],"title":"C22D1: Pain Interference (n=1)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"5.0","value":"3.46"}]}],"title":"End of Treatment: Pain Interference (n=16)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"}],"units":"Participants"}],"description":"m-BPI-sf was a questionnaire designed to assess the severity of pain and the impact of pain on daily functions. m-BPI-sf contained questions that assessed pain severity (worst, least, average, right now) and pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each question was answered on a scale ranging from 0 \"No pain\" to 10 \"Pain as bad as you can imagine\". The 4 pain severity questions were averaged to derive an index of pain severity and the 7 function questions were averaged to derive an index for pain interference. Total score range for pain severity and interference indices: 0 to 10, where higher score indicated higher severity/interference.","dispersionType":"95% Confidence Interval","groups":[{"description":"Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.","id":"OG000","title":"Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)"}],"paramType":"MEAN","populationDescription":"The PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment.'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively.","reportingStatus":"POSTED","timeFrame":"C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)","title":"Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2","type":"SECONDARY","unitOfMeasure":"units on a scale"}