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This interim analysis reports results for patients with CLL, with a median follow-up of 34\u00a0months. Overall, patients had predominantly relapsed\/refractory disease (73%) and were elderly (median age 72\u00a0years) with high-risk features such as del17p and\/or <jats:italic>TP53<\/jats:italic> mutations (59%). Patients were included either prospectively or retrospectively, and the total patient population effectiveness results were adjusted with left truncation. In the effectiveness population (<jats:italic>N<\/jats:italic>\u2009=\u2009221: prospective, <jats:italic>n<\/jats:italic>\u2009=\u200971; retrospective, <jats:italic>n<\/jats:italic>\u2009=\u2009150), the overall response rate was 90.0%. Median progression-free survival was 38.3\u00a0months (prospective, not estimable; retrospective, 51.5\u00a0months) and median overall survival was not yet estimable in the total, prospective and retrospective groups. Treatment-emergent adverse events (TEAEs) for the prospective and retrospective groups are reported separately. Any-grade TEAEs of interest in the prospective\/retrospective groups included infections (67.1%\/60.1%), diarrhea (20.5%\/10.5%), hypertension (16.4%\/9.8%) and atrial fibrillation (12.3%\/7.2%). Major bleeding was reported in 5.5%\/3.3% of prospective\/retrospective patients, with little difference observed between those receiving versus not receiving antithrombotic treatment. Discontinuations due to toxicity were reported in 10.5% of patients. Results from this interim analysis show treatment with ibrutinib to be effective and tolerable, with no new safety signals observed. Future analyses will report on longer-term follow-up.\n<\/jats:p>","DOI":"10.1007\/s44228-022-00020-8","type":"journal-article","created":{"date-parts":[[2022,10,13]],"date-time":"2022-10-13T15:05:42Z","timestamp":1665673542000},"page":"133-143","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) Study"],"prefix":"10.46989","volume":"4","author":[{"given":"Ann","family":"Janssens","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zwi N.","family":"Berneman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fritz","family":"Offner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvia","family":"Snauwaert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Mineur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaetan","family":"Vanstraelen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stef","family":"Meers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Spoormans","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique","family":"Bron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Vande Broek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Van Bogaert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Birgit","family":"De Beleyr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Smet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lasse","family":"Nielsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Wapenaar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Andr\u00e9","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"26435","published-online":{"date-parts":[[2022,10,13]]},"reference":[{"key":"20_CR1","unstructured":"European Medicines Agency. 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ZNB reports research grants from Janssen, Roche, Takeda, CAF-DCF. SM reports consultancy for Janssen. DB reports consultancy and research grant from Janssen. FO reports research grants from Janssen. MA reports consultancy for Takeda, Bristol Myers Squibb, Karyopharm, Gilead\u00a0and Incyte; research grants from Roche, Johnson & Johnson\u00a0and Takeda; travel grants from Roche, Bristol Myers Squib, Celgene, Gilead\u00a0and AbbVie. CVB, BDB, AS, LN and RW are employees of Janssen-Cilag. BDB reports stock ownership from Johnson & Johnson and Pfizer. RW reports stock ownership from Johnson & Johnson. IS, GV, PM, SS and IVB ZB have no conflicts to report.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The study protocol was approved by the institutional review boards or independent ethics committees of participating centers. All patients received oral and written information on the study and provided informed consent to data collection and source data verification.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}