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Table 1 Characteristics of included studies

From: Utility of posaconazole therapeutic drug monitoring and assessment of plasma concentration threshold for effective prophylaxis of invasive fungal infections: a meta-analysis with trial sequential analysis

Study Year Country Study design Patients Population Main underlying disease (%) POS form Indication of therapy Assay method Intervention following TDM result Prophylaxis duration: (days) Definition of successful outcome Cut-off value of prophylaxis AE incidence
Sengar 2016 India SCP 45 A AML sus P HPLC No NA EORTC/MSG Css ≥ 0.7 NA
Döring 2017 Germany SCR 63 C HSCT sus & tab P HPLC No median 106 EORTC/MSG Css ≥ 0.5 hepatotoxicityd
Liebenstein 2017 USA SCR 74 A AML sus & tab P NA Yes 31 & 34 EORTC/MSG Css ≥ 0.7 hepatotoxicity (4.1%)
Tverdek 2017 USA SCR 76 A AML (55%) tab & iv P NA Yes median 8 EORTC/MSG Css ≥ 0.7 NA
Thakuria 2016 UK SCP 26 A lung transplant sus P LC-MS/MS Yes 36.1 EORTC/MSG Css ≥ 0.5 8/27 (29.6%)
Vanstraelen 2016 Belgium SCP 14 C AML (50), ALL (36) sus P HPLC No 21 (17–60) NA Css ≥ 0.7 0
Park 2016 Korea MCP 114 A AML (91), MDS (9) sus P LC-MS/MS Yes ≥ 8 EORTC/MSG Css ≥ 0.5 NA
Cornely 2016 Global(15 countries) MCP, phase III 210 (Css is, available in 186) NA AML (54), MDS (3), HSCT (43) tab P LC-MS/MS No ≥ 28 EORTC/MSG Css ≥ 0.5a, Css ≥ 0.7a 84/210 (40%)
Hummert 2015 USA SCR 29 A AML sus P NA Yes 100 NA Css ≥ 0.5, Css ≥ 0.7 0
Chae 2015 Korea SCP 122 A AML (94) + MDS (6) sus P LC-MS/MS No 25 (7–45) EORTC/MSG Css ≥ 0.5 NA
Maertens 2014 3 European countries MCP, phase III 66 A AML (94) + MDS (6) inj P LC-MS/MS No 1–14 EORTC/MSG Css ≥ 0.5 200 mg/d, 44%, 300 mg/d, 33%
Duarte 2014 Western country MCP, phase III 54 A AML (91) + MDS (9) tab P LC-MS/MS No NA, ≤ 28 EORTC/MSG Css > 0.5 24/54 (44.4%)
Desplanques 2014 France SCR 43 A AML sus P LC-MS/MS No NA EORTC/MSG Css > 0.5 NA
Bourdelin 2014 France SCP 35 A + P HM (AML 49%) sus P HPLC No 5–42 EORTC/MSG Css ≥ 0.5 NA
Gross 2013 Germany SCP 31 (27 P + 4 T) A AML (74), MDS (6) sus P + T HPLC No NA EORTC/MSG Css ≥ 0.7 NA
Cattaneo 2013 Italy SCP 50 NA AML sus P NA No NA EORTC/MSG Css ≥ 0.5 NA
Tonini 2013 France SCR 29 A HSCT sus P LC-MS/MS No NA, ≥ 7 EORTC/MSG Css ≥ 0.7 NA
Ross 2012 USA SCP 54 A AML (95), MDS (5) sus P HPLC No NA, ≥ 7 EORTC/MSG Css ≥ 0.5, Css ≥ 0.7 NA
Pavan 2012 Italy SCR 50 NA AML sus P HPLC Yes NA EORTC/MSG Css ≥ 0.5 NA
Hoenigl 2012 Austria SCP 34 (31 P + 3 T) NA AML/MDS (52), HSCT (48) for prophylaxis sus P + T HPLC No NA EORTC/MSG Css ≥ 0.5 Hepatotoxicity (8.8%)
Eiden 2012 France SCP 63 (50 samples on d7) A leukemia (48%), multiple myeloma (22) sus P HPLC No median 14 (3–307) EORTC/MSG Css ≥ 0.5 b, Css ≥ 0.7 b Hepatotoxicity (6.3%)
Shields 2011 USA SCR 17 (11 P + 6 T) A 16 lung transplant sus P + T HPLC Yes NA EORTC/MSG Css ≥ 0.5, Css ≥ 0.7 NA
Fanci 2011 NA SCP 13 NA AML sus P HPLC No mean 23 NA Css ≥ 0.5 NA
Bryant 2011 USA SCR 21 A AML (95) + MDS (5) sus P HPLC Yes ≥ 7 EORTC/MSG Css ≥ 0.5, Css ≥ 0.7 NA
Welzen 2011 Netherlands MCP, phase II 12 C CGD sus P HPLC Yes ≥ 30 NA Css ≥ 0.5c, Css ≥ 0.7c 4/12 (33.3%)
Lebeaux 2009 France SCR 54 (36 P + 18 T) A HM (69) sus P + T HPLC No ≥ 5 EORTC/MSG Css ≥ 0.5 Hepatotoxicity (7.4%)
Ullmann & Jang 2007 & 2010 Global RCT 291 P (Css is available in 252) NA(> 95% adult) HSCT sus P LC-MS/MS No mean 80 EORTC/MSG Css ≥ 0.7 107/301 (36%)
Cornely & Jang 2007 & 2010 Global RCT 304 P (Css is available in 215) NA AML (84), MDS (16) sus P LC-MS/MS No mean 29 EORTC/MSG Css ≥ 0.7 19/304 SAE (6.2%)
  1. P prophylaxis, T therapeutic, Css steady-state concentrations, NA not available, SCR single-center retrospective, SCP single-center prospective, MCR multicenter retrospective, RCT randomized controlled trial, A adult, C children, HM hematological malignancy, AML acute myeloid leukemia, MDS myelodysplastic syndrome, HSCT hematopoietic stem cell transplantation, GVHD graft versus host disease, CGD chronic granulomatous disease, sus suspension, tab delayed-release tablet, inj injection
  2. a: concentration data gained on day 8
  3. b: data selected from the day 7 based on 50 samples
  4. c: data chosen from day 10
  5. d: the rate of the hepatotoxicity differs from different standards