Table 2.

Treatment-emergent adverse events (≥20% of patients)

	Olaratumab plus Paclitaxel-carboplatin (Arm A) (N = 67)		Paclitaxel-carboplatin (Arm B) (N = 64)
Event	All grades n (%)	Grade ≥3 n (%)	All grades n (%)	Grade ≥3 n (%)
Patients with any adverse event	67 (100)	54 (81)	64 (100)	40 (63)
Fatigue	43 (64)	7 (10)	33 (52)	2 (3)
Alopecia	37 (55)	0	38 (59)	0
Nausea	35 (52)	3 (5)	36 (56)	2 (3)
Neutropenia*	35 (52)	25 (37)	21 (33)	14 (22)
Decreased appetite	31 (46)	1 (2)	19 (30)	0
Thrombocytopenia	29 (43)	9 (13)	15 (23)	3 (5)
Diarrhea	29 (43)	2 (3)	19 (30)	0
Vomiting	28 (42)	0	22 (34)	0
Arthralgia	25 (37)	0	14 (22)	3 (5)
Constipation	24 (36)	1 (2)	27 (42)	0
Anemia	23 (34)	4 (6)	27 (42)	6 (9)
Peripheral neuropathy	23 (34)	2 (3)	18 (28)	1 (2)
Peripheral sensory neuropathy	21 (31)	2 (3)	22 (34)	2 (3)
Mucositis*	19 (28)	1 (2)	10 (16)	0
Insomnia	14 (21)	0	12 (19)	0
Myalgia	14 (21)	1 (2)	15 (23)	2 (3)
Pain in extremity	6 (9)	0	17 (27)	2 (3)
Febrile neutropenia**	4(6)	4 (6)	1 (2)	1 (2)
Adverse Event of Special Interest
Infusion-related reactions***	17 (25)	1 (2)	5 (8)	1 (2)
SAEs
Any SAEs	30 (45)	27 (40)	19 (30)	17 (27)

^*Consolidated term comprising the following synonymous MedDRA preferred terms: neutropenia (leukopenia, neutropenia, neutrophil count decreased, white blood cell count decreased); mucositis (mucosal inflammation, oropharyngeal pain, stomatitis).

^**These events are included here because they were considered clinically important.

^***Infusion-related reactions include a combination of specific preferred terms such as infusion-related reactions, anaphylaxis and signs and symptoms such as flushing and itching.