{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"Grade 3 or Higher TEAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"}],"units":"Participants"}],"description":"An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs occurring after the first dose of study drugs and within 30 days following the last dose of study drug or initiation of subsequent antineoplastic treatment, whichever occurred earlier. TEAEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 as Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4= Life-threatening and Grade 5= Death. Number of participants with TEAEs and Grade 3 or higher TEAEs (included serious and non-serious events) were reported in this outcome measure.","groups":[{"description":"Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.","id":"OG000","title":"Ibrutinib 420 mg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set included all enrolled participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"From start of the treatment (Day 1) up to 30 days after last dose or initiation of subsequent antineoplastic treatment, whichever occurred first (Day 1 up to 45.9 months)","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Grade 3 or Higher TEAEs","type":"SECONDARY","unitOfMeasure":"Participants"}