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Supplementary Table 1. ILTE centers, patients, and PCR assays*

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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 protocols)

2 University of Torino / San Luigi Hospital, Orbassano - Italy

Giuseppe Saglio,MD;

Giovanna Rege Cambrin, MD

46 43 (93) quantitative ( EAC protocols)

4 CEINGE –University of Naples “Federico II”, Napoli - Italy

Fabrizio Pane, MD 77 26 (34) quantitative (EAC protocols)

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

Stagno, MD; Paolo Vigneri, MD

33 31 (94) quantitative (EAC protocols)

7 Hospital of Bergamo, Bergamo - Italy Alessandro Rambaldi, MD 40 38 (95) quantitative (EAC protocols)

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 protocols)

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 protocols)

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 protocols)

16 University of Tor Vergata / S.Eugenio Hospital, Roma - Italy

Elisabetta Abruzzese, MD 34 34 (100) quantitative (EAC protocols)

17 University of Firenze, Firenze - Italy Valeria Santini, MD 29 23 (79) quantitative (EAC protocols)

18 Clinical Research Center University Hospital, Poitiers-Cedex - France

Francois Guilhot, MD 61 47 (77) quantitative (EAC protocols)

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21 Catholic University of Korea, Seoul - Korea Dong-Wook Kim, MD PhD 131 128 (98) quantitative

23 Université Victor Ségalen Bordeaux, Bordeaux - France

Francois Xavier Mahon, MD 107 104 (97) quantitative (EAC protocols)

26 Chaim Sheba Medical Center, Tel Hashomer - Israel

Arnon Nagler, MD 41 40 (98) quantitative

28 Hospital Alemao Osvaldo Cruz, S. Paolo - Brazil

Celso Massumoto, MD no patients entered

no patients entered

-

30 Hospital Angeles del Pedregal Camino a Santa Teresa, M.Contreras - Mexico

Rafael Hurtado Monroy 29 28 (97) na

32 Hospital Universitario Miguel Servet, Zaragoza - Spain

Pilar Giraldo, MD Erardo Merino, MD

10 10 (100) quantitative (EAC protocols)

33 Obafemi Awolowo University, Ile-Ife, Nigeria

Muheez Durosinmi, MD 10 5 (50) na

34 Azienda Ospedaliera Melacrinò Morelli, Reggio Calabria - Italy

Bruno Martino, MD 22 22 (100) quantitative

36 Onze Lieve Vrouwe, Amsterdam - Holland Onno Leeskma, MD 6 3 (50) quantitative (EAC protocols)

*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

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Supplementary Table 2.

Comorbidities present in patients before study entry*

Center No. of patients Cardiovascular, % GI, % Diabetes/ Endocrine, % Nephro-logical, % Respiratory, % Neoplasia, % Neurological/ Psychiatric, % Laboratory

abnormalities† Other Total‡

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

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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.

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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)

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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)

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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.

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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)

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