Table 3 Acute and late toxicities by study arm

Acute period

 General

9 (21%)

—

—

23 (55%)

3 (7.1%)

—

< 0.001

0.241

  Anorexia/dyspepsia

1 (2.4%)

—

—

—

—

—

—

—

  Fatigue

8 (19%)

—

—

22 (52%)

3 (7.1%)

—

< 0.001

0.241

  Flu like symptoms

1 (2.4%)

—

—

—

—

—

—

—

  Gastrointestinal pain

—

—

—

1 (2.4%)

—

—

—

—

  Nausea

—

—

—

1 (2.4%)

—

—

—

—

  Weight loss

—

—

—

1 (2.4%)

—

—

—

—

 Local (breast area)

16 (38%)

—

—

31 (74%)

4 (9.5%)

—

< 0.001

0.116

  Deformation

2 (4.8%)

—

—

8 (19%)

1 (2.4%)

—

0.048

—

  Edema

3 (7.1%)

—

—

15 (36%)

2 (4.8%)

—

< 0.001

0.494

  Pain

5 (12%)

—

—

23 (55%)

2 (4.8%)

—

< 0.001

0.494

  Tumor bed fibrosis

8 (19%)

—

—

12 (29%)

1 (2.4%)

—

0.314

—

 Regional

3 (7.1%)

—

—

9 (21%)

—

—

0.116

—

  Cough

2 (4.8%)

—

—

4 (9.5%)

—

—

0.676

—

  Dyspnea

2 (4.8%)

—

—

2 (4.8%)

—

—

> 0.999

—

  Chest wall pain

1 (2.4%)

—

—

3 (7.1%)

—

—

0.616

—

  Palpitations/cardiac pain

—

—

—

1 (2.4%)

—

—

—

—

  Pneumonitis

—

—

—

1 (2.4%)

—

—

—

—

  Upper limb lymphedema

—

—

—

1 (2.4%)

—

—

—

—

 Skin

29 (69%)

—

—

19 (45%)

22 (52%)

1 (2.4%)

< 0.001

< 0.001

  Desquamation

—

—

—

14 (33%)

7 (17%)

—

< 0.001

0.012

  Dryness

2 (4.8%)

—

—

30 (71%)

1 (2.4%)

—

< 0.001

—

  Edema

5 (12%)

—

—

20 (48%)

2 (4.8%)

—

< 0.001

0.494

  Erythema

21 (50%)

—

—

24 (57%)

17 (40%)

1 (2.4%)

< 0.001

< 0.001

  Hyperpigmentation

11 (26%)

—

—

29 (69%)

9 (21%)

—

< 0.001

0.002

  Tenderness

6 (14%)

—

—

33 (79%)

1 (2.4%)

—

< 0.001

—

Late period

 General

5 (12%)

—

—

3 (7.3%)

—

—

0.713

—

  Fatigue

5 (12%)

—

—

3 (7.3%)

—

—

0.713

—

 Local (breast area)

7 (17%)

—

—

25 (61%)

3 (7.3%)

—

< 0.001

0.116

  Deformation

—

—

—

10 (24%)

2 (4.9%)

—

< 0.001

0.241

  Edema

1 (2.4%)

—

—

7 (17%)

2 (4.9%)

—

0.007

0.241

  Pain

3 (7.1%)

—

—

15 (37%)

—

—

0.001

—

  Tumor bed fibrosis

4 (9.5%)

—

—

11 (27%)

1 (2.4%)

—

0.028

0.494

 Regional

3 (7.1%)

—

—

3 (7.3%)

—

—

> 0.999

—

  Cough

2 (4.8%)

—

—

1 (2.4%)

—

—

> 0.999

—

  Dyspnea

2 (4.8%)

—

—

—

—

—

0.494

—

  Chest wall pain

—

—

—

1 (2.4%)

—

—

0.494

—

  Pneumonitis

—

—

—

1 (2.4%)

—

—

0.494

—

 Skin

9 (21%)

—

—

27 (66%)

5 (12%)

—

< 0.001

0.026

  Atrophy

1 (2.4%)

—

—

3 (7.3%)

—

—

0.360

—

  Dryness

1 (2.4%)

—

—

12 (29%)

1 (2.4%)

—

< 0.001

0.494

  Edema

—

—

—

12 (29%)

3 (7.3%)

—

< 0.001

0.116

  Erythema

2 (4.8%)

—

—

1 (2.4%)

1 (2.4%)

—

> 0.999

0.494

  Hyperpigmentation

6 (14%)

—

—

24 (59%)

2 (4.9%)

—

< 0.001

0.241

  Tenderness

2 (4.8%)

—

—

13 (32%)

—

—

0.002

—