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Table 6 Treatment-emergent adverse events (> 10% any grade; SAF population)

From: Final results from IMPROVE: a randomized, controlled, open-label, two-arm, cross-over phase IV study to determine patients’ preference for everolimus in combination with exemestane or capecitabine in combination with bevacizumab in advanced HR-positive, HER2-negative breast cancer

 

Arm A

Arm B

First-line (Cap+Bev) N = 37

 

Second-line (Eve+Exe) N = 17

 

First-line (Eve+Exe) N = 37

 

Second-line (Cap+Bev) N = 19

 

Any grade

Grade 3/4

Any grade

Grade 3/4

Any grade

Grade 3/4

Any grade

Grade 3/4

Adverse event, n (%)

 Anemia

1 (2.7%)

 

4 (23.5%)

 

5 (13.5%)

   

 Arthralgia

5 (13.5%)

   

4 (10.8%)

 

1 (5.3%)

 

 Bone pain

3 (8.1%)

   

6 (16.2%)

   

 Cough

5 (13.5%)

 

3 (17.6%)

 

6 (16.2%)

 

2 (10.5%)

 

 Decreased appetite

6 (16.2%)

 

1 (5.9%)

 

5 (13.5%)

   

 Diarrhea

12 (32.4%)

 

2 (11.8%)

 

11 (29.7%)

 

5 (26.3%)

 

 Dyspnea

6 (16.2%)

 

3 (17.6%)

 

4 (10.8%)

 

4 (21.1%)

 

 Fatigue

13 (35.1%)

 

3 (17.6%)

 

6 (16.2%)

 

2 (10.5%)

 

 Hand-Foot Syndrome

21 (56.8%)

7 (18.9%)

  

1 (2.7%)

 

6 (31.6%)

2 (10.5%)

 Headache

6 (16.2%)

   

6 (16.2%)

   

 Hypertension

11 (29.7%)

5 (13.5%)

  

2 (5.4%)

 

3 (15.8%)

 

 Mucosal inflammation

4 (10.8%)

 

2 (11.8%)

 

7 (18.9%)

   

 Nausea

15 (40.5%)

 

1 (5.9%)

 

9 (24.3%)

 

5 (26.3%)

 

 Edema peripheral

2 (5.4%)

   

6 (16.2%)

 

2 (10.5%)

 

 Pain

2 (5.4%)

 

2 (11.8%)

2 (11.8%)

1 (2.7%)

   

 Pleural effusion

2 (5.4%)

   

2 (5.4%)

 

3 (15.8%)

 

 Pneumonia

   

2 (11.8%)

3 (8.1%)

   

 PSN

6 (16.2%)

   

1 (2.7%)

 

2 (10.5%)

 

 Stomatitis

9 (24.3%)

 

1 (5.9%)

 

5 (13.5%)

 

1 (5.3%)

 
  1. Percentages in second-line therapy refer to the number of patients, who started second-line therapy. Time range: from first administration of study treatment until 30 days after end of treatment in each treatment line. Unrelated TEAEs starting within 30 days of end of first-line therapy and after start of second-line therapy were considered treatment-emergent in both treatment lines in case second-line therapy had started within 30 days of end of first-line therapy. MedDRA v20.0. PSN = Peripheral sensory neuropathy
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