Skip to main content

Table 4 Common grade adverse drug reactions in the anlotinib or placebo arm in the ALTER0303 trial

From: China National Medical Products Administration approval summary: anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy

Adverse drug reaction Anlotinib arm [cases (%)] Placebo arm [cases (%)]
All grades ≥ 3 grade All grades ≥ 3 grade
General disorder
 Fatigue 150 (51.0) 1 (0.3) 38 (26.6) 0
 Anorexia 133 (45.2) 3 (1.0) 43 (30.1) 3 (2.1)
 Weight loss 66 (22.4) 0 12 (8.4) 0
 Pain 42 (14.3) 2 (0.7) 15 (10.5) 2 (1.4)
Gastrointestinal disorder
 Diarrhea 103 (35.0) 3 (1.0) 21 (14.7) 0
 Oropharyngeal pain 83 (28.2) 1 (0.3) 10 (7.0) 0
 Oral mucositis 68 (23.1) 3 (1.0) 4 (2.8) 0
 Vomiting 63 (21.4) 1 (0.3) 19 (13.3) 0
 Abdominal pain 53 (18.0) 1 (0.3) 13 (9.1) 0
 Nausea 52 (17.7) 0 19 (13.3) 0
 Gum pain 40 (13.6) 0 2 (1.4) 0
Respiratory, thoracic, or mediastinal disorder
 Cough 110 (37.4) 2 (0.7) 33 (23.1) 1 (0.7)
 Dyspnea 90 (30.6) 6 (2.0) 32 (22.4) 7 (4.9)
 Cacophonia 66 (22.4) 2 (0.7) 7 (4.9) 1 (0.7)
 Hemoptysis 58 (19.7) 9 (3.1) 11 (7.7) 2 (1.4)
 Sputum 49 (16.7) 2 (0.7) 16 (11.2) 1 (0.7)
 Upper respiratory infection 33 (11.2) 0 3 (2.1) 0
 Pneumonia 28 (9.5) 12 (4.1) 9 (6.3) 3 (2.1)
 Respiratory failure 10 (3.4) 10 (3.4) 3 (2.1) 3 (2.1)
Cardiovascular disorder
 Hypertension 198 (67.3) 40 (13.6) 23 (16.1) 0
 Sinus tachycardia 105 (35.7) 0 47 (32.9) 0
 QTc prolongations 77 (26.2) 7 (2.4) 27 (18.9) 2 (1.4)
Skin and subcutaneous tissue disorder
 Hand–foot syndrome 128 (43.5) 11 (3.7) 13 (9.1) 0
 Rash 35 (11.9) 0 11 (7.7) 1 (0.7)
Musculoskeletal and connective tissue disorder
 Chest arthralgia 54 (18.4) 1 (0.3) 17 (11.9) 3 (2.1)
 Lumbar and rib pain 42 (14.3) 0 11 (7.7) 0
 Limbs pain 39 (13.3) 0 16 (11.2) 1 (0.7)
Kidney and urinary system disorder
 Proteinuria 85 (28.9) 7 (2.4) 19 (13.3) 1 (0.7)
 Hematuria 41 (13.9) 0 8 (5.6) 0
 Urinary tract infection 33 (11.2) 0 6 (4.2) 0
Endocrine system disorder
 Hypothyroidism 57 (19.4) 1 (0.3) 5 (3.5) 0
Nervous system disorder
 Dizziness 33 (11.2) 0 13 (9.1) 0
 Headache 32 (10.9) 0 5 (3.5) 0
Laboratory test abnormality
 Elevated TSH 137 (46.6) 1 (0.3) 9 (6.3) 0
 Hyper triglycerides 126 (42.9) 9 (3.1) 34 (23.8) 0
 Hypercholesterolemia 119 (40.5) 0 20 (14.0) 0
 Hyper γ-glutamyl transferase 87 (29.6) 13 (4.4) 26 (18.2) 9 (6.3)
 Hyperbilirubinemia 76 (25.9) 5 (1.7) 21 (14.7) 2 (1.4)
 Hyponatremia 66 (22.4) 24 (8.2) 12 (8.4) 5 (3.5)
 Hyper LDL 60 (20.4) 2 (0.7) 11 (7.7) 0
 Lymphocytopenia 55 (18.7) 14 (4.8) 27 (18.9) 8 (5.6)
 Hypoalbuminemia 53 (18.0) 1 (0.3) 18 (12.6) 1 (0.7)
 Elevated alkaline phosphatase 48 (16.3) 7 (2.4) 18 (12.6) 4 (2.8)
 Elevated alanine transaminase 46 (15.6) 2 (0.7) 13 (9.1) 0
 Elevated aspartate transaminase 44 (15.0) 3 (1.0) 15 (10.5) 0
 Hypophosphatemia 31 (10.5) 4 (1.4) 10 (7.0) 2 (1.4)
 Hypokalemia 31 (10.5) 2 (0.7) 7 (4.9) 0
 Thrombocytopenia 30 (10.2) 3 (1.0) 6 (4.2) 0
 Elevated lipase 17 (5.8) 7 (2.4) 2 (1.4) 1 (0.7)
  1. QTc, corrected QT interval; TSH, thyroid stimulating hormone; LDL, low-density lipoprotein