Table 3.

Adverse Events.^*

Adverse Event	Osimertinib (N = 279)		Platinum-Pemetrexed (N = 136)
	Any Grade	Grade ≥3	Any Grade	Grade ≥3
	number (percent)
Diarrhea	113 (41)	3 (1)	15 (11)	2 (1)
Rash†	94 (34)	2 (1)	8 (6)	0
Dry skin†	65 (23)	0	6 (4)	0
Paronychia†	61 (22)	0	2 (1)	0
Decreased appetite	50 (18)	3 (1)	49 (36)	4 (3)
Cough	46 (16)	0	19 (14)	0
Nausea	45 (16)	2 (1)	67 (49)	5 (4)
Fatigue	44 (16)	3 (1)	38 (28)	1 (1)
Stomatitis	41 (15)	0	21 (15)	2 (1)
Constipation	39 (14)	0	47 (35)	0
Pruritus	35 (13)	0	6 (4)	0
Vomiting	31 (11)	1 (<1)	27 (20)	3 (2)
Back pain	29 (10)	1 (<1)	12 (9)	1 (1)
Thrombocytopenia†	28 (10)	1 (<1)	27 (20)	10 (7)
Nasopharyngitis	28 (10)	0	7 (5)	0
Headache	28 (10)	0	15 (11)	0
Dyspnea	24 (9)	3 (1)	18 (13)	0
Neutropenia†	22 (8)	4 (1)	31 (23)	16 (12)
Leukopenia†	22 (8)	0	20 (15)	5 (4)
Anemia†	21 (8)	2 (1)	41 (30)	16 (12)
Asthenia	20 (7)	3 (1)	20 (15)	6 (4)
Pyrexia	18 (6)	0	14 (10)	0
Alanine aminotransferase elevation	18 (6)	3 (1)	15 (11)	1 (1)
Aspartate aminotransferase elevation	14 (5)	3 (1)	15 (11)	1 (1)
Malaise	11 (4)	0	14 (10)	0

^*Listed are adverse events that were reported in at least 10% of the patients in any group. Safety analyses included all the patients who received at least one dose of a trial drug (safety analysis set). Included are adverse events with an on-set date on or after the date of first dose and up to and including 28 days after the discontinuation of the trial drug or the day before the first administration of crossover treatment. Some patients had more than one adverse event.

^†This category represents a grouped term for the event. If a patient had multiple preferred-term level events within a specific grouped term adverse event, then the maximum grade (according to the Common Terminology Criteria for Adverse Events) across those events was counted.