Table 2 Treatment-related acute adverse events

From: Ulinastatin in the treatment of radiotherapy-induced oral mucositis in locoregionally advanced nasopharyngeal carcinoma: a phase 3 randomized clinical trial

 

Patients, no. (%)

       
 

UTI group (n = 89)

   

Control group (n = 90)

   
 

Grade 1

Grade 2

Grade 3

Grade 4

Grade 1

Grade 2

Grade 3

Grade 4

Any acute adverse eventa

9 (10.1)

58 (65.2)

21 (23.6)

1 (1.1)

8 (8.9)

58 (64.4)

24 (26.7)

0

Hematologic toxic effects

 Leukopenia

15 (16.8)

43 (48.3)

13 (14.6)

1 (1.1)

14 (15.5)

45 (50.0)

13 (14.4)

0

 Neutropenia

19 (21.3)

21 (23.5)

4 (4.4)

0

20 (22.2)

13 (14.4)

8 (8.8)

0

 Anemia

29 (32.5)

9 (10.1)

2 (2.2)

0

20 (22.2)

6 (6.7)

0

0

 Thrombocytopenia

7 (7.8)

3 (3.4)

1 (1.1)

0

7 (7.8)

1 (1.1)

1 (1.1)

0

Nonhematologic toxic effects

 Nausea and vomiting

77 (86.5)

12 (13.4)

0

0

76 (84.4)

13 (14.4)

1 (1.1)

0

 Hepatotoxicity

8 (8.9)

2 (2.2)

1 (1.1)

0

7 (7.8)

4 (4.4)

1 (1.1)

0

 Nephrotoxicity

2 (2.2)

3 (3.4)

0

0

5 (5.6)

0

0

0

 Dry mouth

32 (35.9)

45 (50.5)

8 (8.9)

0

31 (34.4)

46 (51.1)

8 (8.9)

0

 Auditory/hearing

32 (35.9)

25 (28.0)

1 (1.1)

0

37 (41.1)

19 (21.1)

6 (6.7)

0

 Skin/neck tissue damage

53 (59.5)

8 (9.0)

0

0

48 (53.3)

3 (3.3)

0

0

  1. UTI ulinastatin.
  2. aAcute adverse events were graded according to the Common Terminology Criteria for Adverse Events (version 5.0).