Table 4.
Grade 3 and 4 Adverse Events, Possibly Related to Study Drug (Safety Population)
| PCb (N=46) |
PC (N=52) |
|||
|---|---|---|---|---|
| Grade 3 n (%) |
Grade 4 n (%) |
Grade 3 n (%) |
Grade 4 n (%) |
|
| Hematologic | ||||
| Anemia | 5 (10.9) | 0 (0.0) | 3 (5.8) | 1 (1.9) |
| Febrile neutropenia | 2 (4.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Leukopenia | 5 (10.9) | 0 (0) | 4 (7.7) | 0 (0) |
| Lymphopenia | 3 (6.5) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Neutropenia | 7 (15.2) | 3 (6.5) | 5 (9.6) | 2 (3.8) |
| Thrombocytopenia | 2 (4.3) | 2 (4.3) | 2 (3.8) | 1 (1.9) |
| Nonhematologic | ||||
| Alanine aminotransferase increased | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Anorexia | 0 (0.0) | 0 (0.0) | 2 (3.8) | 0 (0.0) |
| Aspartate aminotransferase increased | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Asthenia | 0 (0.0) | 0 (0.0) | 2 (3.8) | 0 (0.0) |
| Bronchitis | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Decreased appetite | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Dehydration | 3 (6.5) | 0 (0.0) | 5 (9.6) | 0 (0.0) |
| Diarrhea | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Dysphagia | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dyspnea | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Esophagitis | 2 (4.3) | 0 (0.0) | 2 (3.8) | 1 (1.9) |
| Failure to thrive | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Fatigue | 3 (6.5) | 0 (0.0) | 2 (3.8) | 0 (0.0) |
| Gastritis | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Herpes esophagitis | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Hyperbilirubinemia | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hypokalemia | 3 (6.5) | 0 (0.0) | 2 (3.8) | 0 (0.0) |
| Hyponatremia | 1 (2.2) | 0 (0.0) | 2 (3.8) | 0 (0.0) |
| Hypotension | 2 (4.3) | 0 (0.0) | 4 (7.7) | 0 (0.0) |
| Localized infection | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Mediastinitis | 1 (2.2) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Mucosal inflammation | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Muscular weakness | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Nausea | 2 (4.3) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Neuropathy peripheral | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Orthostatic hypotension | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Pneumonia | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Radiation esophagitis | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Radiation pneumonitis | 1 (2.2) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Renal failure | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Renal failure acute | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Respiratory failure | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Syncope | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Vomiting | 2 (4.3) | 0 (0.0) | 3 (5.8) | 0 (0.0) |
| Weight decreased | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Abbreviations: n=number in group; N=population size; PC=pemetrexed/cisplatin; PCb=pemetrexed/carboplatin.