{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"36"},{"groupId":"OG005","value":"19"},{"groupId":"OG006","value":"30"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"15"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"16"}]}],"title":"TESAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"36"},{"groupId":"OG005","value":"20"},{"groupId":"OG006","value":"31"}],"units":"Participants"}],"description":"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.","groups":[{"description":"Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.","id":"OG000","title":"Phase 1: Venetoclax 300 mg"},{"description":"Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.","id":"OG001","title":"Phase 1: Venetoclax 600 mg"},{"description":"Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.","id":"OG002","title":"Phase 1: Venetoclax 900 mg"},{"description":"Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.","id":"OG003","title":"Phase 1: Venetoclax 1200 mg"},{"description":"Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.","id":"OG004","title":"Phase 1 Safety Expansion: Venetoclax 1200 mg"},{"description":"Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).","id":"OG005","title":"Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg"},{"description":"The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).","id":"OG006","title":"Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population: all participants who received at least one dose of study drug","reportingStatus":"POSTED","timeFrame":"From first dose of study drug until 30 days following last dose of study drug (up to 2482 days)","title":"Number of Participants With Adverse Events","type":"PRIMARY","unitOfMeasure":"Participants"}