{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded according to the common terminology criteria for adverse events (CTCAE) criteria as 1=mild AE, 2=moderate AE, 3=severe AE, 4=life-threatening or disabling AE, 5=Death related to AE. The most severe grade was used in case of multiple occurrences of the same event.","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":"NUMBER","populationDescription":"Safety analysis set (SAS) included all enrolled participants who received at least 1 dose of study treatment.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib","title":"Number of Participants With Adverse Events (AEs) by Severity: Phase 2","type":"SECONDARY","unitOfMeasure":"participants"}