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Table 3 Treatment-related adverse events of special interest in apatinib-exposed patients (n = 1999)

From: Safety and efficacy of apatinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma after the failure of two or more lines of chemotherapy (AHEAD): a prospective, single-arm, multicenter, phase IV study

Treatment-related adverse events of special interest, n (%)

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

All Gradeb

Grade ≥ 3b

Any event

211 (11%)

527 (26%)

883 (44%)

79 (4%)

57 (3%)

1485 (74%)

1019 (51%)

Hypertensiona

127 (6%)

328 (16%)

520 (26%)

5 (< 1%)

0

980 (49%)

525 (26%)

 Hypertension

113 (6%)

300 (15%)

487 (24%)

3 (< 1%)

0

903 (45%)

490 (25%)

Proteinuriaa

126 (6%)

142 (7%)

61 (3%)

1 (< 1%)

0

685 (34%)

89 (4%)

 Proteinuria

252 (13%)

201 (10%)

76 (4%)

1 (< 1%)

0

530 (27%)

77 (4%)

Hand-foot syndromea

126 (6%)

142 (7%)

61 (3%)

1 (< 1%)

0

330 (17%)

62 (3%)

Overall bleedinga

338 (17%)

100 (5%)

64 (3%)

12 (1%)

26 (1%)

540 (27%)

102 (5%)

 Gastrointestinal hemorrhage

56 (3%)

49 (2%)

37 (2%)

12 (1%)

23 (1%)

177 (9%)

72 (4%)

 CNS bleeding

0

0

0

1 (< 1%)

2 (< 1%)

3 (< 1%)

3 (< 1%)

 Laboratory abnormality

258 (13%)

43 (2%)

12 (1%)

1 (< 1%)

0

314 (16%)

13 (1%)

 Fecal occult blood positive

238 (12%)

39 (2%)

11 (< 1%)

0

0

288 (14%)

11 (< 1%)

Hepatotoxicitya

295 (15%)

155 (8%)

126 (6%)

19 (1%)

5 (< 1%)

600 (30%)

150 (8%)

 Laboratory abnormality

237 (12%)

117 (6%)

97 (5%)

9 (< 1%)

0

460 (23%)

106 (5%)

 Alanine aminotransferase increase

115 (6%)

34 (2%)

20 (1%)

0

0

169 (8%)

20 (1%)

 Aspartate aminotransferase increase

179 (9%)

42 (2%)

25 (1%)

1 (< 1%)

0

247 (12%)

26 (1%)

 Serum bilirubin increase

122 (6%)

59 (3%)

28 (1%)

5 (< 1%)

0

214 (11%)

33 (2%)

 Hepatobiliary disease

91 (5%)

52 (3%)

36 (2%)

11 (1%)

5 (< 1%)

195 (10%)

52 (3%)

 Hepatic injury

76 (4%)

43 (2%)

30 (2%)

5 (< 1%)

4 (< 1%)

158 (8%)

39 (2%)

Cardiac toxicity a

31 (2%)

9 (1%)

7 (< 1%)

0

0

47 (2%)

7 (< 1%)

  1. aBaskets of MedDRA version 22.0 adverse events preferred terms were used
  2. bPatients could have more than one grade of the same event