Table 1 Summary of report characteristics, patient demographics, transplant type, and disease parameters
Study quality factors | Defibrotide-treated | Age | Transplant | Common underlying diseases | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Reference* | Prospective? | Type | Control | Total | MOD | No MOD | Median | ≤ 16 years | > 16 years | Auto | Allo | ALL | AML | Other | |
Richardson 1998 [1] | Yes | Single center | No | 19 | 19 | 0 | 40 | 3 | 16 | 11 | 8 | 1 | 3 | 15 | |
Chopra 2000 [2] | Yes | CU | No | 40 | 26 | 14 | 30 | 11 | 29 | 14 | 26 | 6 | 14 | 20 | |
Richardson 2002 [3] | Yes | CU | No | 88 | 88 | 0 | 35 | 29a | 59a | 28 | 60 | 6 | 22 | 60 | |
Corbacioglu 2004 [4] | No | CU | No | 45 | 22 | 23 | 8.2 | 40 | 5 | 8 | 37 | 6 | 10 | 29 | |
Bulley 2007 [5] | No | Single center | No | 14 | NR | NR | 10.2 | 14b | 0b | 0 | 14 | 3 | 1 | 10 | |
Sucak 2007 [6] | No | Single center | No | 14 | 6 | 8 | 40.5 | 0b | 14b | 1 | 13 | 4 | 5 | 5 | |
Richardson 2010 [7] | Yes | Phase 2, dose finding | No | 149 | 149 | 0 | 34 | 48a | 101a | 20 | 129 | 15 | 47 | 87 | |
Ruiz Ramos 2014 [8] | No | Observational | No | 11 | NR | NR | NR | 4 | 5 | NR | NR | NR | NR | NR | |
Locatelli 2015 [9] | Yes | CU | No | 98 | 17 | 77 | 13.4 | 52a | 42a | 10 | 75 | 18 | 23 | 57 | |
Triplett 2015 [10] | Yes | Single center | No | 34 | 22 | 12 | 8.9 | 31a | 3a | 2 | 29 | 10 | 10 | 14 | |
Balade Martinez 2016 [11] | No | Observational | No | 42 | 42 | 0 | 46 | 12 | 30 | NR | NR | NR | NR | NR | |
Corbacioglu 2016 [12] | Yes | CU | No | 710 | 261 | 348 | 25 | 303a | 407a | 112 | 499 | 120 | 177 | 413 | |
Pol 2016 [13] | No | Single center | No | 13 | 12 | 1 | 60.5 | 0 | 13 | 0 | 13 | 0 | 7 | 6 | |
Richardson 2016 [14] | Yes | Phase 3 | Historical | 102 | 102 | 0 | 21 | 44 | 58 | 12 | 90 | 17 | 29 | 56 | |
Strouse 2016 [15] | No | Registry | Not treated | 41 | 41 | 0 | 11 | 25 (61) | 16 (39) | 2 (5) | 39 (95) | 19c | 22 | ||
Yakushijin 2016 [16] | No | Registry | Thrombo-modulin | 24 | NR | NR | 40 | NR | NR | 0 | 65 | NR | NR | NR | |
Richardson 2017 (T-IND) [17] | Yes | T-IND | No | 1154 | 571 | NR | 12 | 691 | 463 | 155 | 843 | 279 | 279 | 596 |