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