Table 2.
TEAE n (%) | Tecemotide + Cyclophosphamide (n = 79) | Placebo + Saline (n = 42) |
---|---|---|
Any grade, n (%) | 69 (87.3%) | 40 (95.2%) |
Grade 3/4, n (%) | 23 (29.1%) | 11 (26.2%) |
Treatment-related, n (%) | 38 (48.1%) | 20 (47.6%) |
Treatment-related Grade 3/4, n (%) | 4 (5.1%) | 0 (0%) |
Fatal TEAE, n (%) | 2 (2.5%) | 0 (0%) |
TEAEs are represented for the number (%) of patients for the two treatment arms respectively (each patient is counted once). Grading according to NCI-CTCAE Version 3.0. Abbreviations: NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events, TEAE: treatment-emergent adverse event