Table 4.
Adverse events occurring at grades 1–2 in ≥10% or at grade 3 or grade4a in ≥2% of patients with ALK-rearranged NSCLC
| Adverse event | Patients with ALK-rearranged NSCLC treated with 750 mg/day (N=246) |
||
|---|---|---|---|
| Grade 1–2 n (%) |
Grade 3 n (%) |
Grade 4 n (%) |
|
| Diarrhoea | 198 (80.5) | 15 (6.1) | 0 (0.0) |
| Nausea | 190 (77.2) | 15 (6.1) | 0 (0.0) |
| Vomiting | 139 (56.5) | 11 (4.5) | 0 (0.0) |
| Fatigue | 94 (38.2) | 12 (4.9) | 0 (0.0) |
| Abdominal pain | 91 (37.0) | 3 (1.2) | 0 (0.0) |
| Decreased appetite | 89 (36.2) | 4 (1.6) | 0 (0.0) |
| Constipation | 75 (30.5) | 0 (0.0) | 0 (0.0) |
| Cough | 71 (28.9) | 0 (0.0) | 0 (0.0) |
| Abdominal pain, upper | 57 (23.2) | 2 (0.8) | 0 (0.0) |
| Dyspnoea | 52 (21.1) | 9 (3.7) | 1 (0.4) |
| Back pain | 49 (19.9) | 1 (0.4) | 0 (0.0) |
| Headache | 47 (19.1) | 4 (1.6) | 0 (0.0) |
| Asthenia | 45 (18.3) | 2 (0.8) | 0 (0.0) |
| Weight decreased | 41 (16.7) | 4 (1.6) | 0 (0.0) |
| Insomnia | 37 (15.0) | 0 (0.0) | 0 (0.0) |
| Pyrexia | 37 (15.0) | 0 (0.0) | 0 (0.0) |
| Musculoskeletal pain | 36 (14.6) | 0 (0.0) | 0 (0.0) |
| Rash | 33 (13.4) | 0 (0.0) | 0 (0.0) |
| Dizziness | 31 (12.6) | 0 (0.0) | 0 (0.0) |
| Dyspepsia | 30 (12.2) | 1 (0.4) | 0 (0.0) |
| Arthralgia | 26 (10.6) | 0 (0.0) | 0 (0.0) |
| Musculoskeletal chest pain | 26 (10.6) | 0 (0.0) | 0 (0.0) |
| Anaemia | 18 (7.3) | 12 (4.9) | 0 (0.0) |
| Pneumonia | 13 (5.3) | 12 (4.9) | 0 (0.0) |
| Convulsion | 7 (2.8) | 7 (2.8) | 1 (0.4) |
| Pneumonitis | 1 (0.4) | 6 (2.4) | 1 (0.4) |
| Respiratory failure | 0 (0.0) | 1 (0.4) | 5 (2.0) |
| Laboratory Abnormalities | |||
| Aspartate aminotransferase increased | 56 (22.8) | 20 (8.1) | 5 (2.0) |
| Blood creatinine increased | 42 (17.1) | 0 (0.0) | 0 (0.0) |
| Alanine aminotransferase increased | 36 (14.6) | 66 (26.8) | 7 (2.8) |
| Blood alkaline phosphatase increased | 31 (12.6) | 13 (5.3) | 0 (0.0) |
| Hypokalaemia | 17 (6.9) | 10 (4.1) | 1 (0.4) |
| Amylase increased | 10 (4.1) | 7 (2.8) | 1 (0.4) |
| Hyponatraemia | 8 (3.3) | 11 (4.5) | 0 (0.0) |
| Hypophosphataemia | 8 (3.3) | 8 (3.3) | 0 (0.0) |
| Lipase increased | 8 (3.3) | 13 (5.3) | 3 (1.2) |
| Gamma-glutamyl transferase increased | 7 (2.8) | 6 (2.4) | 1 (0.4) |
| Hyperglycaemia | 6 (2.4) | 12 (4.9) | 3 (1.2) |
a
Grade 5 adverse events were not specifically recorded, per the protocol. However, there were two deaths during the study that were considered to be related to study drug: one from interstitial lung disease and the other from multi-organ failure.
ALK=anaplastic lymphoma kinase. NSCLC=non-small-cell lung cancer.