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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 AArm 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 gradeGrade 3/4Any gradeGrade 3/4Any gradeGrade 3/4Any gradeGrade 3/4
Adverse event, n (%)
 Anemia1 (2.7%) 4 (23.5%) 5 (13.5%)   
 Arthralgia5 (13.5%)   4 (10.8%) 1 (5.3%) 
 Bone pain3 (8.1%)   6 (16.2%)   
 Cough5 (13.5%) 3 (17.6%) 6 (16.2%) 2 (10.5%) 
 Decreased appetite6 (16.2%) 1 (5.9%) 5 (13.5%)   
 Diarrhea12 (32.4%) 2 (11.8%) 11 (29.7%) 5 (26.3%) 
 Dyspnea6 (16.2%) 3 (17.6%) 4 (10.8%) 4 (21.1%) 
 Fatigue13 (35.1%) 3 (17.6%) 6 (16.2%) 2 (10.5%) 
 Hand-Foot Syndrome21 (56.8%)7 (18.9%)  1 (2.7%) 6 (31.6%)2 (10.5%)
 Headache6 (16.2%)   6 (16.2%)   
 Hypertension11 (29.7%)5 (13.5%)  2 (5.4%) 3 (15.8%) 
 Mucosal inflammation4 (10.8%) 2 (11.8%) 7 (18.9%)   
 Nausea15 (40.5%) 1 (5.9%) 9 (24.3%) 5 (26.3%) 
 Edema peripheral2 (5.4%)   6 (16.2%) 2 (10.5%) 
 Pain2 (5.4%) 2 (11.8%)2 (11.8%)1 (2.7%)   
 Pleural effusion2 (5.4%)   2 (5.4%) 3 (15.8%) 
 Pneumonia   2 (11.8%)3 (8.1%)   
 PSN6 (16.2%)   1 (2.7%) 2 (10.5%) 
 Stomatitis9 (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