Table 1 Summary of report characteristics, patient demographics, transplant type, and disease parameters

From: Publisher Correction: Systematic review of defibrotide studies in the treatment of veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS)

 

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

  1. ALL, acute lymphocytic leukemia; Allo, allogeneic; AML, acute myelogenous leukemia; Auto, autologous; CU, compassionate use; MOD, multi-organ dysfunction; NR, not reported; T-IND, defibrotide expanded access program
  2. aPediatric defined as ≤ 18 years and adults as > 18 years
  3. bInclusive of age 16 years
  4. cAcute leukemias
  5. *These references are listed in accordance with the correction article, however in the original article the reference numbers differ, as they are in accordance with the original article