{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"161"}],"units":"Participants"}],"description":"Grade 5 AEs were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.","groups":[{"description":"All participants in this study received both study drugs and were therefore analysed together as a single treatment arm.\n\nParticipants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment.\n\nThe study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.","id":"OG000","title":"Acalabrutinib + Pembrolizumab"}],"paramType":"NUMBER","populationDescription":"All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the safety of the combination study treatment.","reportingStatus":"POSTED","timeFrame":"104 weeks","title":"Number of Participants With Any Grade 5 Study Drug-Related SAE","type":"PRIMARY","unitOfMeasure":"Number of participants"}