Table 3 Summary of late adverse events

From: Final survival analysis of induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by concurrent chemoradiotherapy in nasopharyngeal carcinoma: a multicenter, randomized, phase 3 trial

 

Lobaplatin-based therapy group (n = 252)

Cisplatin-based therapy group (n = 249)

p for events grade 1–2

p for events grade 3

Any

Grades 1–2

Grade 3

Any

Grades 1–2

Grade 3

p1

p2

p1

p2

Dry mouth

189

(75)

180

(71.4)

9

(3.6)

184

(73.9)

175

(69.4)

9

(3.6)

0.777

0.877

0.979

0.851

Cranial neuropathy

17

(6.7)

14

(5.6)

3

(1.2)

19

(7.6)

17

(6.7)

2

(0.8)

0.555

0.277

0.663

0.488

Peripheral neuropathy

17

(6.7)

15

(6)

2

(0.8)

29

(11.6)

28

(11.2)

1

(0.4)

0.034

0.033

0.570

0.614

Eye damage

4

(1.6)

3

(1.2)

1

(0.4)

4

(1.6)

3

(1.2)

1

(0.4)

0.988

0.810

1.000 a

0.975

Ear (deafness/otitis)

104

(41.3)

88

(34.9)

16

(6.3)

138

(55.4)

116

(46)

22

(8.7)

0.008

0.021

0.293

0.418

Neck tissue damage

90

(35.7)

83

(32.9)

7

(2.8)

97

(38.9)

88

(34.9)

9

(3.6)

0.570

0.458

0.594

0.453

Bone necrosis

8

(3.2)

6

(2.4)

2

(0.8)

11

(4.4)

7

(2.8)

4

(1.6)

0.762

0.546

0.403

0.577

Symptomatic temporal lobe necrosis

15

(5.9)

15

(5.9)

0

(0)

14

(5.6)

14

(5.6)

0

(0)

0.874

0.971

0.247 a

1.000

Trismus

17

(6.7)

16

(6.3)

1

(0.4)

14

(5.6)

13

(5.2)

1

(0.4)

0.589

0.763

1.000 a

0.960

Dysphagia

7

(2.8)

7

(2.8)

0

(0)

7

(2.8)

6

(2.5)

1

(0.4)

0.796

0.945

0.497 a

0.997

Nephrotoxicity

7

(2.8)

6

(2.4)

1

(0.4)

32

(12.8)

22

(8.8)

10

(4)

0.002

0.005

0.006

0.021

  1. Data are n (%).
  2. p1 is univariable analyses. p2 is multivariable analyses. These analyses were conducted in the safety analysis population, who received at least one cycle of induction chemotherapy. No grads 4–5 adverse events occurred during the treatment and follow-up course. As prespecified by protocol, differences in late adverse events were analyzed using the χ2 test; for late adverse events that did not meet the requirement for χ2 test, Fisher’s exact test was used. a p values were calculated with Fisher’s exact test.
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