Supplementary Table 1. ILTE centers, patients, and PCR assays* Center PI/Co-PI No. registered patients No. eligibile patients () Type of PCR 1 University of Milano Bicocca, Monza - Italy Carlo Gambacorti-Passerini, MD 67 63 (94) quantitative (EAC 2 University of Torino / San Luigi Hospital, Orbassano - Italy Giuseppe Saglio,MD; Giovanna Rege Cambrin, MD 46 43 (93) quantitative ( EAC 4 CEINGE University of Naples Federico II, Napoli - Italy Fabrizio Pane, MD 77 26 (34) quantitative (EAC 5 S. Bortolo Hospital, Vicenza - Italy Anna D Emilio, MD 34 33 (97) qualitative 6 University of Catania, Catania - Italy Francesco Di Raimondo, MD; Fabio 33 31 (94) quantitative (EAC Stagno, MD; Paolo Vigneri, MD 7 Hospital of Bergamo, Bergamo - Italy Alessandro Rambaldi, MD 40 38 (95) quantitative (EAC 8 Hospital of Bolzano, Bolzano - Italy Sergio Cortelazzo, MD 22 17 (77) quantitative 9 San Giovanni Battista Hospital, Torino - Italy Patrizia Pregno, MD 11 11 (100) quantitative 10 University of Torino, Torino Italy Dario Ferrero, MD patients enrolled using center #9 11 SS Antonio e Biagio Hospital, Alessandria - Italy Massimo Pini, MD; Alessandro Levis MD ; - - 9 9 (100) quantitative (EAC 12 S. Croce Hospital, Cuneo - Italy Andrea Gallamini, MD no patients entered no patients entered 13 University of Berlin, Berlin - Germany Philipp le Coutre, MD 34 28 (82) quantitative (EAC 14 Jewish General Hospital Montreal - Canada Sarit Assouline, MD 11 9 (82) quantitative 15 Niguarda Cà Granda Hospital Milan - Italy Enrica Morra, MD Ester Pungolino, MD 35 35 (100) quantitative (EAC 16 University of Tor Vergata / S.Eugenio Hospital, Roma - Italy Elisabetta Abruzzese, MD 34 34 (100) quantitative (EAC 17 University of Firenze, Firenze - Italy Valeria Santini, MD 29 23 (79) quantitative (EAC 18 Clinical Research Center University Hospital, Poitiers-Cedex - France Francois Guilhot, MD 61 47 (77) quantitative (EAC 19 University of Oregon, Portland OR - USA Michael Deininger, MD 49 46 (94) quantitative
21 Catholic University of Korea, Seoul - Korea Dong-Wook Kim, MD PhD 131 128 (98) quantitative 23 Université Victor Ségalen Bordeaux, Bordeaux - France 26 Chaim Sheba Medical Center, Tel Hashomer - Israel 28 Hospital Alemao Osvaldo Cruz, S. Paolo - Brazil 30 Hospital Angeles del Pedregal Camino a Santa Teresa, M.Contreras - Mexico 32 Hospital Universitario Miguel Servet, Zaragoza - Spain 33 Obafemi Awolowo University, Ile-Ife, Nigeria 34 Azienda Ospedaliera Melacrinò Morelli, Reggio Calabria - Italy Francois Xavier Mahon, MD 107 104 (97) quantitative (EAC Arnon Nagler, MD 41 40 (98) quantitative Celso Massumoto, MD no patients no patients - entered entered Rafael Hurtado Monroy 29 28 (97) na Pilar Giraldo, MD Erardo Merino, MD 10 10 (100) quantitative (EAC Muheez Durosinmi, MD 10 5 (50) na Bruno Martino, MD 22 22 (100) quantitative 36 Onze Lieve Vrouwe, Amsterdam - Holland Onno Leeskma, MD 6 3 (50) quantitative (EAC *ILTE = Imatinib long-term effects; PI/Co-PIs= principal investigator/co-principal investigator; PCR = polymerase chain reaction; EAC= Europe Against Cancer (Leukemia, 20, 886 888, 2006); n.a.= not available; CEINGE = Centro di Ingegneria Genetica
Supplementary Table 2. Comorbidities present in patients before study entry* Center No. of patients Cardiovascular, GI, Diabetes/ Endocrine, Nephrological, Respiratory, Neoplasia, Neurological/ Psychiatric, Laboratory abnormalities Other Monza, Italy 63 21.0 21.0 4.8 6.3 3.2 6.3 3.2. 11.0 76.8 Orbassano, Italy 43 21.0 2.3 2.3 2.3 4.7 12.0. 2.3 2,3 49.2 Napoli, Italy 26 15.0 3.8 3.8.. 3.8.. 12.0 38.4 Vicenza, Italy 33 9.1 3.0 3.0 3.0 3.0. 3.0. 21.0 45.1 Catania, Italy 31 23.0. 9.7 3.2. 6.5... 42.4 Bergamo, Italy 38 26.0 16.0 11.0 11.0 13.0 2.6 5.3 2.6 13.0 100.0 Bolzano, Italy 17 29.0 5.9. 5.9.. 5.9.. 46.7 Torino, Italy 10 30.0 10.0... 10.0... 50.0 Alessandria, Italy 9 11.0.. 11.0.. 11.0.. 33.0 Berlin, Germany 28 25.0 11.0 11.0 7.1 11.0 11.0 3.6. 14.0 93.7 Montreal, Canada 9 22.0 11.0. 11.0 11.0... 11.0 66.0 Milano, Italy 35 20.0 11.0 5.7 8.6. 5.7.. 2.9 53.9 Roma, Italy 34 12.0 21.0 5.9 5.9 5.9 2.9 2,9 2.9 15.0 74.4 Firenze, italy 23 8.7 35.0 8.7.. 4.3.. 8.7 65.4 Poitiers, France 47 17.0. 8.5 4.3 2.1 13.0.. 2.1 47.0 Portland, USA 46 30.0 8.7 4.3 2.2 11.0 6.5 6.5 4.3 39.0 112.5 Seoul, Korea 128 3.9 6.3 6.3 5.5 3.1 3.1. 0.8 3.9 32.9 Total
Bordeaux, France 104 29.0 14.0 13.0 5.8 5.8 7.7 22.0 2.9 8.7 108.9 Tel- Hashomer, Israel 40 15.0 13.0 7.5 5.0 7.5 2.5. 7.5 18.0 76.0 Mexico City, Mexico 28 7.1. 3.6 3.6 3.6.... 17.9 Zaragoza, Spain 10 30.0 10.0 10.0... 10.0. 10.0 70.0 Ile-Ife, Nigeria 5 20.0. 20.0...... 40.0 Reggio Calabria, Italy 22 18.0 9.1. 4.5 9.1 18.0.. 9.1 67.8 Amsterdam, Holland 3 67.0........ 67.0 Total 832 18.0 9.9 6.7 4.9 4.6 5.6 4.3 1.4 9.5 64.9 *Percentages of 832 patients. GI = gastrointestinal. Laboratory abnormalities, eg, increased creatin kinase or uric acid values A patient could have more than one comorbidity.
Supplementary Table 3. Previous neoplasias present in patients before study entry* Neoplasia No. () Bladder 5 (0.6) Breast 18 (2.2) Cervical 1 (0.1) Central nervous system 1 (0.1) Colon 2 (0.2) Gastrointestinal stromal tumors 1 (0.1) Melanoma 1 (0.1) Non Hodgkin lymphoma 5 (0.6) Pancreas 1 (0.1) Prostate 6 (0.7) Renal 1 (0.1) Testis 1 (0.1) Thyroid 3 (0.4) Uterus 1 (0.1) Total 47 (5.6) * of 832 patients. Median age of 47 patients with previous neoplasia (43 male) is 63 years for men and 58 years for women.
Supplementary Table 4. Association of SAEs to imatinib therapy* Relationship to imatinib use No. () Certain 4 (2.9) Probable 2 (1.4) Possible 21 (15.1) Not likely 45 (32.4) Not related 43 (30.9) Missing 1 (0.7) Not known 23 (16.6) Total 139 (100.0) * of the total number of events. SAE = serious adverse events
Supplementary Table 5. Second neoplasias developed during ILTE study follow-up* Type No. () Adrenal gland 1 (0.1) Biliary tract 1 (0.1) Bladder 1 (0.1) Breast 3 (0.4) Central Nervous System 1 (0.1) Colon 3 (0.3) Endometrium 1 (0.1) Lung 2 (0.2) Non Hodgkin Lymphoma 1 (0.1) Ph- Leukemia 1 (0.1) Prostate 10 (1.2) Renal 2 (0.2) Salivary gland 1 (0.1) Skin, squamous cell 2 (0.2) Total 30 (3.6) * of 832 patients. ILTE = Imatinib long-term effects. Ph- negative Philadelphia chromosome in acute myeloid leukemia.
Supplementary Table 6. Association of NSAEs to imatinib therapy * Relationship to imatinib use No. () Certain 171 (20.6) Probable 233 (28.1) Possible 156 (18.8) Not likely 112 (13.5) Not related 93 (11.2) Missing 17 (2.0) Not known 48 (5.8) Total 830 (100.0) * of the total number of events. NSAE = Non-serious adverse events.