Skip to main content

Table 5 Any grade AEs (≥10%) and corresponding Grade 3 or 4 AEs (Safety population)

From: A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer

  BTH1677/
Bevacizumab/
Carboplatin/Paclitaxel
(N = 59)
Bevacizumab/
Carboplatin/Paclitaxel
(N = 30)
Adverse events (AEs), n (%) All AEs Grade 3 or Grade 4 AEs All AEs Grade 3 or Grade 4 AEs
Patients with at least 1 AE 58 (98.3) 55 (93.2) 30 (100.0) 20 (66.7)
Blood and lymphatic system disorders
 Neutropenia 26 (44.1) 23 (39.0) 10 (33.3) 8 (26.7)
 Thrombocytopenia 20 (33.9) 11 (18.6) 10 (33.3) 5 (16.7)
 Anemia 14 (23.7) 2 (3.4) 8 (26.7) 1 (3.3)
 Leukopenia 9 (15.3) 3 (5.1) 2 (6.7) 1 (3.3)
Gastrointestinal disorders
 Nausea 40 (67.8) 5 (8.5) 16 (53.3) 0
 Constipation 25 (42.4) 0 9 (30.0) 0
 Vomiting 19 (32.2) 2 (3.4) 7 (23.3) 0
 Diarrhea 12 (20.3) 2 (3.4) 8 (26.7) 1 (3.3)
 Abdominal pain upper 6 (10.2) 1 (1.7) 1 (3.3) 0
 Stomatitis 6 (10.2) 1 (1.7) 0 0
General disorders and administration-site conditions
 Fatigue 33 (55.9) 1 (1.7) 18 (60.0) 1 (3.3)
 Pyrexia 12 (20.3) 2 (3.4) 3 (10.0) 0
 Chills 11 (18.6) 1 (1.7) 0 0
 Mucosal inflammation 6 (10.2) 0 3 (10.0) 0
 Chest pain 3 (5.1) 0 5 (16.7) 0
Infections and infestations
 Nasopharyngitis 6 (10.2) 0 3 (10.0) 0
 Urinary tract infection 2 (3.4) 1 (1.7) 3 (10.0) 0
Injury, poisoning, and procedural complications
 Infusion-related reaction 7 (11.9) 1 (1.7) 2 (6.7) 1 (3.3)
Investigations
 Hemoglobin decreased 4 (6.8) 1 (1.7) 3 (10.0) 2 (6.7)
 Platelet count decreased 3 (5.1) 2 (3.4) 3 (10.0) 1 (3.3)
Metabolism and nutritional disorders
 Decreased appetite 17 (28.8) 1 (1.7) 11 (36.7) 0
 Hypokalemia 6 (10.2) 1 (1.7) 0 0
Musculoskeletal and connective tissue disorders
 Arthralgia 19 (32.2) 1 (1.7) 6 (20.0) 0
 Pain in extremity 15 (25.4) 0 3 (10.0) 0
 Back pain 11 (18.6) 1 (1.7) 4 (13.3) 0
 Myalgia 12 (20.3) 1 (1.7) 2 (6.7) 0
Nervous system disorders
 Polyneuropathy 16 (27.1) 3 (5.1) 6 (20.0) 0
 Headache 9 (15.3) 1 (1.7) 4 (13.3) 0
 Neuropathy peripheral 6 (10.2) 0 5 (16.7) 0
 Dizziness 7 (11.9) 0 3 (10.0) 0
 Paresthesia 7 (11.9) 0 2 (6.7) 0
 Dysgeusia 6 (10.2) 0 2 (6.7) 0
Psychiatric disorders
 Insomnia 9 (15.3) 0 2 (6.7) 0
 Sleep disorder 5 (8.5) 0 4 (13.3) 0
Respiratory, thoracic and mediastinal disorders
 Dyspnea 18 (30.5) 3 (5.1) 8 (26.7) 0
 Cough 18 (30.5) 2 (3.4) 7 (23.3) 0
 Epistaxis 14 (23.7) 0 10 (33.3) 0
 Oropharyngeal pain 8 (13.6) 0 2 (6.7) 0
Skin and subcutaneous tissue disorders
 Alopecia 28 (47.5) 2 (3.4) 14 (46.7) 0
Vascular disorders
 Hypertension 14 (23.7) 3 (5.1) 7 (23.3) 1 (3.3)
  1. Abbreviations: AE adverse events, N overall sample size, n number of patients