Table 2 Most frequently reported (patient level) adverse events by primary system organ class and preferred term (occurring at any grade in ≥20% or at grade ≥3 in ≥5% patients in either treatment group) during the phase-II portion
Adverse event (SOC and PT) | Nintedanib, 200 mg bid (n = 62) | Sorafenib, 400 mg bid (n = 31) | ||
|---|---|---|---|---|
All grades, n (%) | Grade ≥3, n (%) | All grades, n (%) | Grade ≥3, n (%) | |
Patients with any adverse event | 62 (100) | 42 (67.7) | 31 (100) | 28 (90.3) |
Blood and lymphatic system disorders | 10 (16.1) | 5 (8.1) | 8 (25.8) | 6 (19.4) |
Anaemia | 6 (9.7) | 4 (6.5) | 1 (3.2) | 1 (3.2) |
Thrombocytopenia | 2 (3.2) | 1 (1.6) | 4 (12.9) | 3 (9.7) |
Gastrointestinal disorders | 60 (96.8) | 16 (25.8) | 29 (93.5) | 3 (9.7) |
Diarrhoea | 44 (71.0) | 8 (12.9) | 21 (67.7) | 1 (3.2) |
Nausea | 30 (48.4) | 1 (1.6) | 9 (29.0) | 0 (0.0) |
Vomiting | 24 (38.7) | 2 (3.2) | 9 (29.0) | 0 (0.0) |
Abdominal pain | 16 (25.8) | 0 (0.0) | 9 (29.0) | 1 (3.2) |
Abdominal pain upper | 16 (25.8) | 0 (0.0) | 4 (12.9) | 0 (0.0) |
General disorders and administration site conditions | 44 (71.0) | 11 (17.7) | 21 (67.7) | 4 (12.9) |
Fatigue | 35 (56.5) | 7 (11.3) | 10 (32.3) | 1 (3.2) |
Investigations | 24 (38.7) | 14 (22.6) | 17 (54.8) | 11 (35.5) |
AST increased | 11 (17.7) | 7 (11.3) | 5 (16.1) | 1 (3.2) |
ALT increased | 8 (12.9) | 5 (8.1) | 3 (9.7) | 2 (6.5) |
Metabolism and nutrition disorders | 26 (41.9) | 4 (6.5) | 18 (58.1) | 4 (12.9) |
Decreased appetite | 23 (37.1) | 1 (1.6) | 13 (41.9) | 1 (3.2) |
Neoplasms benign, malignant and unspecified (including cysts and polyps) | 6 (9.7) | 4 (6.5) | 4 (12.9) | 3 (9.7) |
Malignant neoplasm progression | 2 (3.2) | 2 (3.2) | 3 (9.7) | 3 (9.7) |
Nervous system disorders | 20 (32.3) | 7 (11.3) | 16 (51.6) | 2 (6.5) |
Hepatic encephalopathy | 5 (8.1) | 5 (8.1) | 2 (6.5) | 1 (3.2) |
Lethargy | 5 (8.1) | 0 (0.0) | 8 (25.8) | 1 (3.2) |
Skin and subcutaneous tissue disorders | 27 (43.5) | 2 (3.2) | 25 (80.6) | 11 (35.5) |
Rash | 6 (9.7) | 0 (0.0) | 7 (22.6) | 1 (3.2) |
Alopecia | 3 (4.8) | 0 (0.0) | 11 (35.5) | 0 (0.0) |
Palmar–plantar erythrodysesthesia syndrome | 1 (1.6) | 0 (0.0) | 11 (35.5) | 7 (22.6) |
Skin reaction | 1 (1.6) | 1 (1.6) | 3 (9.7) | 2 (6.5 |
