Table 3. Adverse Events.
Osimertinib+Carboplatin (N=142)
Osimertinib Monotherapy (N=147)
Any Grade Grade 1 Grade 2 Grade 3 Grade 4 Any Grade Grade 1 Grade 2 Grade 3 Grade 4
Anemia 127 (89) 50 (35) 63 (44) 14 (10) 0 65 (44) 50 (34) 14 (10) 1 (1) 0
Neutrophil count decreased 110 (77) 13 (9) 45 (32) 35 (25) 17 (12) 40 (27) 18 (12) 16 (11) 6 (4) 0
White blood cell count decreased 108 (76) 21 (15) 54 (38) 29 (20) 4 (3) 47 (32) 24 (16) 23 (16) 0 0
Stomatitis 89 (63) 55 (39) 30 (21) 4 (3) 0 65 (44) 39 (27) 22 (15) 4 (3) 0
Platelet count decreased 87 (61) 19 (13) 36 (25) 18 (13) 13 (9) 25 (17) 21 (14) 3 (2) 1 (1) 0
Blood creatinine increased 85 (60) 62 (44) 21 (15) 2 (1) 0 67 (46) 49 (33) 17 (12) 1 (1) 0
Diarrhea 85 (60) 53 (37) 26 (18) 6 (4) 0 75 (51) 63 (43) 9 (6) 3 (2) 0
AST increased 84 (59) 69 (49) 14 (10) 1 (1) 0 41 (28) 39 (27) 2 (1) 0 0
Rash 84 (59) 61 (43) 23 (16) 0 0 70 (48) 53 (36) 16 (11) 1 (1) 0
Decreased appetite 76 (54) 60 (42) 13 (9) 3 (2) 0 36 (24) 32 (22) 4 (3) 0 0
ALT increased 75 (53) 63 (44) 11 (8) 1 (1) 0 42 (29) 39 (27) 3 (2) 0 0
Blood creatine phosphokinase increased 72 (51) 50 (35) 16 (11) 3 (2) 3 (2) 71 (48) 50 (34) 18 (12) 3 (2) 0
Constipation 67 (47) 50 (35) 16 (11) 1 (1) 0 25 (17) 19 (13) 6 (4) 0 0
Fatigue 65 (46) 50 (35) 12 (8) 3 (2) 0 32 (22) 27 (18) 3 (2) 2 (1) 0
Hypoalbuminemia 60 (42) 55 (39) 5 (4) 0 0 36 (24) 33 (22) 3 (2) 0 0
Hyponatremia 54 (38) 53 (37) 1 (1) 0 0 57 (39) 54 (37) 3 (2) 0 0
Nausea 50 (35) 35 (25) 12 (8) 3 (2) 0 24 (16) 22 (15) 2 (1) 0 0
Cough 49 (35) 37 (26) 12 (8) 0 0 42 (29) 37 (25) 5 (3) 0 0
Lymphocyte count decreased 47 (33) 25 (18) 14 (10) 8 (6) 0 61 (41) 40 (27) 19 (13) 2 (1) 0
Insomnia 46 (32) 34 (24) 11 (8) 1 (1) 0 37 (25) 31 (21) 5 (3) 1 (1) 0
Paronychia 46 (32) 35 (25) 11 (8) 0 0 34 (23) 23 (16) 11 (7) 0 0
Blood cholesterol increased 42 (30) 41 (29) 1 (1) 0 0 10 (7) 9 (6) 1 (1) 0 0
Hypoaesthesia 40 (28) 28 (20) 12 (8) 0 0 26 (18) 26 (18) 0 0 0
Alopecia 37 (26) 31 (22) 6 (4) 0 0 25 (17) 25 (17) 0 0 0
Vomiting 37 (26) 25 (18) 11 (8) 1 (1) 0 20 (14) 17 (12) 3 (2) 0 0
Dyspnoea 30 (21) 24 (17) 5 (4) 1 (1) 0 26 (18) 24 (16) 2 (1) 0 0
Hypocalcemia 30 (21) 23 (16) 7 (5) 0 0 40 (27) 33 (22) 6 (4) 1 (1) 0
Musculoskeletal pain 29 (20) 27 (19) 2 (1) 0 0 24 (16) 21 (14) 3 (2) 0 0
Dizziness 28 (20) 23 (16) 4 (3) 0 0 9 (6) 9 (6) 0 0 0
Hypokalemia 28 (20) 26 (18) 1 (1) 1 (1) 0 17 (12) 14 (10) 3 (2) 0 0
Blood triglycerides increased 27 (19) 25 (18) 2 (1) 0 0 20 (14) 19 (13) 1 (1) 0 0
Blood uric acid increase 27 (19) 27 (19) 0 0 0 19 (13) 19 (13) 0 0 0
Pain 27 (19) 23 (16) 4 (3) 0 0 19 (13) 13 (9) 6 (4) 0 0
COVID-19 25 (18) 21 (15) 4 (3) 0 0 21 (14) 20 (14) 0 0 1 (1)
Hyperglycemia 25 (18) 25 (18) 0 0 0 12 (8) 12 (8) 0 0 0
Pyrexia 25 (18) 21 (15) 4 (3) 0 0 10 (7) 10 (7) 0 0 0
Blood urine present 23 (16) 23 (16) 0 0 0 12 (8) 12 (8) 0 0 0
Edema face 22 (15) 21 (15) 1 (1) 0 0 2 (1) 2 (1) 0 0 0
Edema limbs 22 (15) 20 (14) 2 (1) 0 0 4 (3) 4 (3) 0 0 0
Skin hyperpigmentation 22 (15) 21 (15) 1 (1) 0 0 4 (3) 4 (3) 0 0 0
Hypermagnesemia 16 (11) 14 (10) 2 (1) 0 0 32 (22) 30 (20) 2 (1) 0 0
  • Safety analyses included all the patients who received at least one dose of trial treatment (safety analysis set), according to the treatment received. Each patient has been represented only once with the maximum reported Common Terminology Criteria for Adverse Events grade for each preferred term. Listed are adverse events from any cause according to preferred term that were reported in at least 15% of patients in either group. Adverse events with an onset date on or after the date of first dose and up to and including 28 days after the discontinuation of treatment but before the start of a subsequent anticancer therapy are reported. ALT denotes alanine aminotransferase, and AST aspartate aminotransferase.