Table 2 Comparison of fatal and non-fatal outcomes of spontaneous reports of MTX-related ADRs

Age, in years

(n = 57)

(n = 190)

(n = 42)

(n = 549)

Mean (SD)

67.5 (12.7)

65.3 (13.9)

0.279

67.5 (16.7)

58.9 (13.5)

< 0.001

Median (Q1-Q3)

69.0 (60.0–76.0)

65.5 (58.0–76.0)

71.0 (59.0-78.3)

59.0 (50.0–67.0)

Sex

(n = 76)

(n = 280)

1.000

(n = 58)

(n = 972)

0.881

Female

53 (69.7%)

193 (68.9%)

41 (70.7%)

696 (71.6%)

Male

23 (30.3%)

87 (31.1%)

17 (29.3%)

276 (28.4%)

Comorbidity

(n = 58)

(n = 204)

(n = 43)

(n = 427)

Cancerous

5 (8.6%)

24 (11.8%)

0.638

7 (16.3%)

34 (8.0%)

0.084

Comedication

(n = 77)

(n = 288)

(n = 60)

(n = 982)

Any comedication

67 (87.0%)

235 (81.6%)

0.311

52 (86.7%)

613 (62.4%)

< 0.001

Any NSAID²

19 (24.7%)

67 (23.3%)

0.765

12 (20.0%)

154 (15.7%)

0.365

Acetaminophen

14 (18.2%)

36 (12.5%)

0.196

13 (21.7%)

83 (8.5%)

0.002

Metamizole

9 (11.7%)

16 (5.6%)

0.074

6 (10.0%)

17 (1.7%)

0.001

Non-MTX DMARD

32 (41.6%)

117 (40.6%)

0.897

25 (41.7%)

343 (34.9%)

0.330

bDMARD

28 (36.4%)

70 (24.3%)

0.042

17 (28.3%)

223 (22.7%)

0.343

csDMARD

12 (15.6%)

55 (19.1%)

0.619

11 (18.3%)

141 (14.4%)

0.449

tsDMARD

1 (1.3%)

8 (3.1%)

0.695

1 (1.7%)

13 (1.3%)

0.566

Corticosteroids

33 (42.9%)

106 (36.8%)

0.356

23 (38.3%)

227 (23.1%)

0.012

Folic acid

25 (32.5%)

90 (31.3%)

0.890

18 (30.0%)

203 (20.7%)

0.103

MTX use

Route

(n = 58)

(n = 197)

(n = 51)

(n = 759)

Oral

42 (72.4%)

135 (68.5%)

0.629

38 (74.5%)

525 (69.2%)

0.530

Subcutan/Subdermal

12 (20.7%)

35 (17.8%)

0.700

10 (19.6%)

166 (21.9%)

0.861

Duration in months

(n = 45)

(n = 178)

(n = 34)

(n = 725)

Mean (SD)

31.8 (44.5)

49.5 (68.8)

0.038

43.4 (60.9)

30.4 (52.0)

0.159

Median (Q1-Q3)

11.0 (1.7–50.8)

16.5 (3.6–74.5)

18.7 (2.0-60.5)

9.7 (2.7–34.1)

ADR

(n = 77)

(n = 288)

(n = 60)

(n = 982)

On kidneys and liver

21 (27.3%)

46 (16.0%)

0.031

21 (35.0%)

46 (4.7%)

< 0.001