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Table 3 Treatment-emergent adverse events (> 5 %) in any group in cycle 1

From: Randomized phase III trial of APF530 versus palonosetron in the prevention of chemotherapy-induced nausea and vomiting in a subset of patients with breast cancer receiving moderately or highly emetogenic chemotherapy

Adverse Eventsa APF530
250 mg SC
APF530
500 mg SC
Palonosetron
0.25 mg IV
n = 219 n = 464 n = 211 n = 468 n = 199 n = 463
Breast Cancer Overall Breast Cancer Overall Breast Cancer Overall
At least one adverse event 166 (75.8) 315 (67.9) 161 (76.3) 317 (67.7) 147 (73.9) 313 (67.6)
Preferred term,b n (%)  
 Asthenia 11 (5.0) 23 (5.0) 10 (4.7) 22 (4.7) 15 (7.5) 30 (6.5)
 Constipation 30 (13.7) 62 (13.4) 38 (18.0) 72 (15.4) 25 (12.6) 62 (13.4)
 Diarrhea 24 (11.0) 49 (10.6) 25 (11.8) 44 (9.4) 20 (10.1) 39 (8.4)
 Fatigue 42 (19.2) 62 (13.4) 37 (17.5) 62 (13.2) 32 (16.1) 52 (11.2)
 Headache 24 (11.0) 31 (6.7) 33 (15.6) 47 (10.0) 28 (14.1) 45 (9.7)
 Insomnia 12 (5.5) 20 (4.3) 10 (4.7) 25 (5.3) 3 (1.5) 11 (2.4)
Injection-site reactions,b n (%)  
 Bruising 41 (18.7) 78 (16.8) 54 (25.6) 93 (19.9) 21 (10.6) 41 (8.9)
 Erythema 14 (6.4) 33 (7.1) 26 (12.3) 51 (10.9) 9 (4.5) 14 (3.0)
 Nodule 12 (5.5) 22 (4.7) 32 (15.2) 50 (10.7) 1 (0.5) 3 (0.6)
 Pain 11 (5.0) 16 (3.4) 25 (11.4) 33 (7.1) 3 (1.5) 5 (1.1)
  1. aA patient with more than 1 event represented by a given preferred term was counted once within that preferred term
  2. bExcludes hematologic adverse events (anemia, leukopenia, neutropenia), abdominal pain, alopecia, and vomiting, which were assumed to be related to chemotherapy
  3. IV intravenously, SC subcutaneously