Table 4

The most common treatment-emergent adverse events for the overall study period (≥10.0% )
TEAE, n (%) All Treated Patients (n = 106)a Randomized Patients (n = 55)b
Pemetrexed/BSC (n = 28) BSC (n = 27)
All Grades Grade 3/4 All Grades Grade 3/4 All Grades Grade 3/4
Vomiting 38 (35.8) 2 (1.9)c 11 (39.3) 0 (0.0) 8 (29.6) 1 (3.7)c
Fatigue 27 (25.5) 4 (3.8)d 5 (17.9) 1 (3.6)c 8 (29.6) 1 (3.7)
Decreased appetite 26 (24.5) 2 (1.9)e 8 (28.6) 0 (0.0) 5 (18.5) 0 (0.0)
Anemia 17 (16.0) 8 (7.5)f 6 (21.4) 2 (7.1)f 6 (22.2) 3 (11.1)c
Cough 15 (14.2) 1 (0.9) 3 (10.7) 0 (0.0) 4 (14.8) 0 (0.0)
Dyspnea 12 (11.3) 2 (1.9) 3 (10.7) 0 (0.0) 5 (18.5) 1 (3.7)
Nausea 15 (14.2) 0 (0.0) 6 (21.4) 0 (0.0) 4 (14.8) 0 (0.0)
Chest pain 12 (11.3) 0 (0.0) 6 (21.4) 0 (0.0) 3 (11.1) 0 (0.0)
Neutropenia 12 (11.3) 9 (8.5)c 4 (14.3) 3 (10.7)c 5 (18.5) 3 (11.1)c

Abbreviations: BSC = best supportive care; TEAE = treatment-emergent adverse event.

aThe most common TEAEs for the overall study period in the group of patients who were enrolled into the induction phase and who received at least 1 dose of study therapy. This includes the patients who were randomized into the maintenance phase (n = 55) and the patients who were not randomized (n = 51).

bThe most common TEAEs during induction and maintenance therapy in the patients randomized to the maintenance phase arms.

cConsidered to be study drug-related.

dTwo (1.9%) patients experienced grade 3 or 4 drug-related fatigue.

eOne (0.9%) patient experienced grade 3 or 4 drug-related decreased appetite.

fSix (5.7%) patients in the all treated patient population and 1 (3.6%) randomized patient in the pemetrexed/BSC arm experienced drug-related grade 3 or 4 anemia.

Mubarak et al.

Mubarak et al. BMC Cancer 2012 12:423   doi:10.1186/1471-2407-12-423

Open Data