Table 4.
Most Common AEs (All Causality) in ≥ 20% of Patients, Any Grade, in Either Treatment Group
| AEs by Preferred Term | Ceritinib 750 mg N = 76 |
Chemotherapy N = 75 |
||
|---|---|---|---|---|
| Any Grade, n (%) | Grade 3 or 4, n (%) | Any Grade, n (%) | Grade 3 or 4, n (%) | |
| Total | 76 (100) | 60 (78.9) | 73 (97.3) | 50 (66.7) |
| Diarrhea | 65 (85.5) | 4 (5.3) | 12 (16.0) | 1 (1.3) |
| ALT increased | 56 (73.7) | 29 (38.2) | 17 (22.7) | 1 (1.3) |
| Vomiting | 56 (73.7) | 4 (5.3) | 32 (42.7) | 7 (9.3) |
| AST increased | 53 (69.7) | 16 (21.1) | 20 (26.7) | 1 (1.3) |
| Nausea | 53 (69.7) | 1 (1.3) | 37 (49.3) | 5 (6.7) |
| Decreased appetite | 28 (36.8) | 0 | 28 (37.3) | 1 (1.3) |
| Fatigue | 28 (36.8) | 6 (7.9) | 22 (29.3) | 4 (5.3) |
| GGT increased | 27 (35.5) | 17 (22.4) | 9 (12.0) | 1 (1.3) |
| Cough | 22 (28.9) | 0 | 13 (17.3) | 0 |
| Blood ALP increased | 21 (27.6) | 2 (2.6) | 3 (4.0) | 0 |
| Blood creatinine increased | 21 (27.6) | 2 (2.6) | 5 (6.7) | 0 |
| Weight decreased | 21 (27.6) | 3 (3.9) | 12 (16.0) | 1 (1.3) |
| Pyrexia | 20 (26.3) | 0 | 13 (17.3) | 2 (2.7) |
| Abdominal pain | 18 (23.7) | 2 (2.6) | 5 (6.7) | 0 |
| Anemia | 17 (22.4) | 4 (5.3) | 30 (40.0) | 10 (13.3) |
| Back pain | 16 (21.1) | 1 (1.3) | 12 (16.0) | 0 |
| Rash | 16 (21.1) | 1 (1.3) | 7 (9.3) | 0 |
| Constipation | 13 (17.1) | 0 | 18 (24.0) | 0 |
| Dyspnea | 12 (15.8) | 2 (2.6) | 17 (22.7) | 5 (6.7) |
| WBC count decreased | 6 (7.9) | 0 | 21 (28.0) | 6 (8.0) |
| Neutrophil count decreased | 5 (6.6) | 2 (2.6) | 19 (25.3) | 8 (10.7) |
| Neutropenia | 3 (3.9) | 0 | 15 (20.0) | 7 (9.3) |
Note: A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple AEs is counted only once in the total row. Only AEs occurring during the on-treatment period are summarized. Missing grades are included under the “any grade” column. MedDRA v19.0 was used. AEs were graded according to the CTCAE v4.03.
AE, adverse event; ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE v4.03, Common Terminology Criteria for Adverse Events version 4.03; GGT, gamma-glutamyl transferase; MedDRA v19.0, medical dictionary for regulatory activities version 19.0; WBC, white blood cell.