Table 2 Treatment-emergent adverse events occurring in ≥ 10% of patients
Grade | Arm A (N=21) | Arm B (N=7) | Arm C (N=17) | Overall (N=45) | ||||
|---|---|---|---|---|---|---|---|---|
Epertinib + T | Epertinib + T + V | Epertinib + T + C | ||||||
all, n (%) | ≥3, n (%) | all, n (%) | ≥3, n (%) | all, n (%) | ≥3, n (%) | all, n (%) | ≥3, n (%) | |
Gastrointestinal disorders | ||||||||
Diarrhoea | 20 (95.2) | 8 (38.1) | 7 (100) | 3(42.9) | 16 (94.1) | 5 (29.4) | 43 (95.6) | 16 (35.6) |
Nausea | 17 (81.0) | 1 (4.8) | 7 (100) | 0 | 12 (70.6) | 0 | 36 (80.0) | 1 (2.2) |
Vomiting | 7 (33.3) | 1 (4.8) | 4 (57.1) | 1 (14.3) | 6 (35.3) | 0 | 17 (37.8) | 2 (4.4) |
Stomatitis | 6 (28.6) | 0 | 0 | 0 | 5 (29.4) | 0 | 11 (24.4) | 0 |
Constipation | 3 (14.3) | 0 | 2 (28.6) | 0 | 3 (17.6) | 0 | 8 (17.8) | 0 |
Abdominal Pain | 4 (19.0) | 0 | 1 (14.3) | 0 | 2 (11.8) | 0 | 7 (15.6) | 0 |
Dyspepsia | 1 (4.8) | 0 | 1 (14.3) | 0 | 3 (17.6) | 0 | 5 (11.1) | 0 |
Metabolism and nutrition disorders | ||||||||
Decreased appetite | 9 (42.9) | 0 | 2 (28.6) | 0 | 6 (35.3) | 1 (5.9) | 17 (37.8) | 1 (2.2) |
Hypokalaemia | 4 (19.0) | 0 | 1 (14.3) | 1 (14.3) | 6 (35.3) | 3 (17.6) | 11 (24.4) | 4 (8.9) |
General disorders | ||||||||
Fatigue | 5 (23.8) | 0 | 3 (42.9) | 1 (14.3) | 6 (35.3) | 0 | 14 (31.1) | 1 (2.2) |
Oedema peripheral | 2 (9.5) | 0 | 0 | 0 | 4 (23.5) | 0 | 6 (13.3) | 0 |
Pyrexia | 2 (9.5) | 0 | 2 (28.6) | 0 | 2 (11.8) | 0 | 6 (13.3) | 0 |
Asthenia | 1 (4.8) | 0 | 0 | 0 | 4 (23.5) | 0 | 5 (11.1) | 0 |
Skin and subcutaneous tissue disorders | ||||||||
Palmar-plantar erythrodysaesthesia syndrome | 2 (9.5) | 0 | 0 | 0 | 11 (64.7) | 1 (5.9) | 13 (28.9) | 1 (2.2) |
Rash | 5 (23.8) | 0 | 2 (28.6) | 0 | 4 (23.5) | 0 | 11 (24.4) | 0 |
Pruritus | 6 (28.6) | 0 | 0 | 0 | 2 (11.8) | 0 | 8 (17.8) | 0 |
Dermatitis acneiform | 6 (28.6) | 0 | 0 | 0 | 0 | 0 | 6 (13.3) | 0 |
Blood system disorders | ||||||||
Anaemia | 3 (14.3) | 1 (4.8) | 0 | 0 | 6(35.3) | 0 | 9 (20.0) | 1 (2.2) |
Neutropenia | 1 (4.8) | 0 | 4 (57.1) | 4 (57.1) | 2(11.8) | 1 (5.9) | 7 (15.6) | 5 (11.1) |
Infections and infestations | ||||||||
Paronychia | 1 (4.8) | 0 | 2 (28.6) | 0 | 6 (35.3) | 0 | 9 (20.0) | 0 |
Upper respiratory tract infection | 3 (14.3) | 0 | 2 (28.6) | 0 | 1 (5.9) | 0 | 6 (13.3) | 0 |
Urinary tract infection | 2 (9.5) | 0 | 0 | 0 | 4 (23.5) | 0 | 6 (13.3) | 0 |
Respiratory disorders | ||||||||
Dyspnoea | 2 (9.5) | 1 (4.8) | 1 (14.3) | 0 | 5 (29.4) | 1 (5.9) | 8 (17.8) | 2 (4.4) |
Epistaxis | 3 (14.3) | 0 | 2 (28.6) | 0 | 3 (17.6) | 0 | 8 (17.8) | 0 |
Cough | 3 (14.3) | 0 | 1 (14.3) | 0 | 2 (11.8) | 0 | 6 (13.3) | 0 |
Nervous system disorders | ||||||||
Headache | 4 (19.0) | 0 | 1 (14.3) | 0 | 2(11.8) | 0 | 7 (15.6) | 0 |
Lethargy | 2 (9.5) | 0 | 3 (42.9) | 0 | 1 (5.9) | 0 | 6 (13.3) | 0 |
Musculoskeletal disorder | ||||||||
Muscle spasms | 2 (9.5) | 0 | 1 (14.3) | 0 | 2 (11.8) | 0 | 5 (11.1) | 0 |
Eye disorder | ||||||||
Dry eye | 1 (4.8) | 0 | 1 (14.3) | 0 | 3 (17.6) | 0 | 5 (11.1) | 0 |
Investigations | ||||||||
Blood bilirubin increased | 10 (47.6) | 1 (4.8) | 2 (28.6) | 0 | 10 (58.8) | 3 (17.6) | 22 (48.9) | 4 (8.9) |
ALT increased | 3 (14.3) | 0 | 5 (71.4) | 0 | 2 (11.8) | 1 (5.9) | 10 (22.2) | 1 (2.2) |
AST increased | 2 (9.5) | 0 | 3 (42.9) | 0 | 4 (23.5) | 1 (5.9) | 9 (20.0) | 1 (2.2) |
Weight decreased | 2 (9.5) | 0 | 0 | 0 | 3 (17.6) | 0 | 5 (11.1) | 0 |