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Table 4 The most common treatment-emergent adverse events for the overall study period (≥10.0% )

From: A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer

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

  1. Abbreviations: BSC = best supportive care; TEAE = treatment-emergent adverse event.
  2. 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).
  3. bThe most common TEAEs during induction and maintenance therapy in the patients randomized to the maintenance phase arms.
  4. cConsidered to be study drug-related.
  5. dTwo (1.9%) patients experienced grade 3 or 4 drug-related fatigue.
  6. eOne (0.9%) patient experienced grade 3 or 4 drug-related decreased appetite.
  7. 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.