Table 2 Adverse events.

From: High-dose alkylating chemotherapy in BRCA-altered triple-negative breast cancer: the randomized phase III NeoTN trial

  

ddAC

ddAC-CD

ddAC-CP

All conventional

High-dose

 

Grade

n = 24

n = 7

n = 36

n = 67

n = 53

Fatigue

Any

12 (50%)

3 (43%)

11 (31%)

26 (39%)

47 (89%)

 

34

2 (8%)

1 (14%)

0 (0%)

3 (4%)

21 (40%)

Nausea

Any

5 (21%)

0 (0%)

2 (6%)

7 (10%)

40 (75%)

 

34

1 (4%)

0 (0%)

0 (0%)

1 (1%)

13 (25%)

Infectiona

Any

3 (13%)

2 (29%)

3 (8%)

8 (12%)

33 (62%)

 

34

0 (0%)

1 (14%)

1 (3%)

2 (3%)

29 (55%)

Mucositis oral

Any

7 (29%)

2 (29%)

1 (3%)

10 (15%)

25 (47%)

 

34

2 (8%)

1 (14%)

0 (0%)

3 (4%)

10 (19%)

Diarrhea

Any

1 (4%)

2 (29%)

0 (0%)

3 (4%)

23 (43%)

 

34

0 (0%)

0 (0%)

0 (0%)

0 (0%)

7 (13%)

Vomiting

Any

2 (8%)

0 (0%)

0 (0%)

2 (3%)

22 (42%)

 

34

0 (0%)

0 (0%)

0 (0%)

0 (0%)

6 (11%)

Allergic reaction

Any

0 (0%)

1 (14%)

0 (0%)

1 (1%)

19 (36%)

 

34

0 (0%)

0 (0%)

0 (0%)

0 (0%)

3 (6%)

Skin related adverse eventsb

Any

2 (8%)

6 (86%)

1 (3%)

9 (13%)

10 (19%)

34

0 (0%)

2 (29%)

1 (3%)

3 (4%)

1 (2%)

Pain

Any

0 (0%)

0 (0%)

1 (3%)

1 (1%)

14 (26%)

 

34

0 (0%)

0 (0%)

0 (0%)

0 (0%)

4 (8%)

Gastritis, reflux or dyspepsiac

Any

2 (8%)

0 (0%)

1 (3%)

3 (4%)

10 (19%)

34

0 (0%)

0 (0%)

0 (0%)

0 (0%)

2 (4%)

Peripheral sensory neuropathy

Any

2 (8%)

3 (43%)

5 (14%)

10 (15%)

1 (2%)

34

1 (4%)

0 (0%)

1 (3%)

2 (3%)

0 (0%)

Weight loss

Any

3 (13%)

0 (0%)

0 (0%)

3 (4%)

6 (12%)

 

34

0 (0%)

0 (0%)

0 (0%)

0 (0%)

0 (0%)

  1. Excluding the first three cycles of ddAC. Grade 1 adverse events were not registered. All non -hematological adverse events with a frequency for grade 2–4 of at least 10% in either the conventional or high-dose treatment arm are listed. acombined all infection CTCAE terms and includes febrile neutropenia.
  2. bcombined CTCAE “rash”, “palmar-plantar erythrodysesthesia syndrome” and “pruritus”,.
  3. ccombined CTCAE “gastritis”, “gastroesophageal reflux disease” and “dyspepsia”.