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Table 3 Treatment-emergent, all-causality adverse events and laboratory abnormalities in ≥20% of patients in any treatment arm a

From: Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer

Adverse events, n(%) Arm I: Axitinib (Continuous) + Pem/Cis Arm II: Axitinib (Modified) + Pem/Cis Arm III: Pem/Cis Alone
  All Grade All Grade All Grade
  Grades 3/4 Grades 3/4 Grades 3/4
  n= 55 n= 55 n= 58 n= 58 n= 55 n= 55
Nausea 38 (69) 10 (18) 30 (52) 3 (5) 33 (60) 4 (7)
Hypertension 37 (67) 11 (20) 28 (48) 10 (17) 6 (11) 0
Vomiting 29 (53) 8 (15) 19 (33) 3 (5) 16 (29) 2 (4)
Decreased appetite 28 (51) 4 (7) 28 (48) 4 (7) 23 (42) 2 (4)
Fatigue 27 (49) 6 (11) 25 (43) 9 (16) 25 (45) 9 (16)
Diarrhea 21 (38) 4 (7) 20 (34) 3 (5) 9 (16) 0
Constipation 20 (36) 0 15 (26) 1 (2) 23 (42) 1 (2)
Neutropenia 17 (31) 7 (13) 12 (21) 6 (10) 15 (27) 5 (9)
Dyspnea 13 (24) 3 (5) 14 (24) 2 (3) 10 (18) 3 (5)
Insomnia 13 (24) 0 8 (14) 1 (2) 11 (20) 0
Dysphonia 12 (22) 0 8 (14) 0 0 0
Cough 11 (20) 1 (2) 7 (12) 0 9 (16) 2 (4)
Headache 11 (20) 0 17 (29) 1 (2) 9 (16) 0
Anemia 7 (13) 3 (5) 20 (34) 8 (14) 23 (42) 6 (11)
Laboratory abnormalities, n / N b (%)
Hyperglycemia 40/53 (75) 1/53 (2) 36/55 (65) 3/55 (5) 33/52 (63) 2/52 (4)
Hypoalbuminemia 26/50 (52) 1/50 (2) 31/54 (57) 1/54 (2) 23/50 (46) 0
Hypokalemia 23/53 (43) 0 17/55 (31) 1/55 (2) 10/52 (19) 0
Creatinine 22/54 (41) 2/54 (4) 29/55 (53) 5/55 (9) 24/53 (45) 3/53 (6)
Hyponatremia 18/54 (33) 3/54 (6) 18/55 (33) 7/55 (13) 11/52 (21) 1/52 (2)
Alkaline phosphatase 16/53 (30) 0 23/55 (42) 0 15/53 (28) 0
Hyperkalemia 16/53 (30) 2/53 (4) 26/55 (47) 2/55 (4) 19/52 (37) 2/52 (4)
ALT 15/53 (28) 1/53 (2) 23/55 (42) 1/55 (2) 12/53 (23) 2/53 (4)
Bicarbonate 8/30 (27) 0 17/38 (45) 1/38 (3) 13/39 (33) 0
AST 10/53 (19) 1/53 (2) 21/55 (38) 1/55 (2) 10/53 (19) 2/53 (4)
  1. Abbreviations: Pem/Cis Pemetrexed/cisplatin, ALT Alanine aminotransferase, AST Aspartate aminotransferase.
  2. aBased on data cutoff date of December 21, 2011.
  3. bDenominator for each laboratory abnormality differed depending on the availability of baseline and at least one test result during the study treatment.