Table 4.

Common treatment-emergent adverse events and serious adverse events by preferred term (safety population)

	MB02 (N = 311)		EU-bevacizumab (N = 310)
	Grade 1–2	Grade ≥3	Grade 1–2	Grade ≥3
TEAEs by PT in ≥5% subjects in either treatment group
Alopecia	151 (48.6)	4 (1.3)	162 (52.3)	1 (0.3)
Anemia	75 (24.1)	26 (8.4)	73 (23.5)	21 (6.8)
Thrombocytopenia	31 (10.0)	10 (3.2)	36 (11.6)	6 (1.9)
Neutropenia	18 (5.8)	16 (5.1)	24 (7.7)	21 (6.8)
Leukopenia	20 (6.4)	4 (1.3)	15 (4.8)	3 (1.0)
Neuropathy peripheral	36 (11.6)	2 (0.6)	38 (12.3)	3 (1.0)
Peripheral sensory neuropathy	21 (6.8)	1 (0.3)	21 (6.8)	2 (0.6)
Paresthesia	21 (6.8)	0	12 (3.9)	1 (0.3)
Headache	11 (3.5)	1 (0.3)	17 (5.5)	0
Fatigue	33 (10.6)	6 (1.9)	30 (9.7)	6 (1.9)
Asthenia	25 (8.0)	14 (4.5)	18 (5.8)	11 (3.5)
General physical health deterioration	5 (1.6)	18 (5.8)	9 (2.9)	20 (6.5)
Weight decreased	21 (6.8)	2 (0.6)	25 (8.1)	2 (0.6)
Platelet count decreased	20 (6.4)	6 (1.9)	16 (5.2)	3 (1.0)
Alanine aminotransferase increased	11 (3.5)	4 (1.3)	17 (5.5)	4 (1.3)
Aspartate aminotransferase increased	9 (2.9)	5 (1.6)	17 (5.5)	5 (1.6)
Nausea	47 (15.1)	0	44 (14.2)	0
Diarrhea	28 (9.0)	1 (0.3)	24 (7.7)	3 (1.0)
Vomiting	21 (6.8)	1 (0.3)	10 (3.2)	1 (0.3)
Myalgia	22 (7.1)	1 (0.3)	30 (9.7)	0
Arthralgia	17 (5.5)	2 (0.6)	20 (6.5)	0
Respiratory tract infection viral	16 (5.1)	0	16 (5.2)	0
Cough	19 (6.1)	1 (0.3)	21 (6.8)	1 (0.3)
Decreased appetite	13 (4.2)	1 (0.3)	19 (6.1)	1 (0.3)
Hypertension	17 (5.5)	7 (2.3)	19 (6.1)	7 (2.3)
Proteinuria	17 (5.5)	1 (0.3)	21 (6.8)	4 (1.3)

	Any grade		Any grade
Serious TEAEs by PT in ≥1% of subjects in either treatment group
Pneumonia	8 (2.6)		8 (2.6)
Empyema	3 (1.0)		0
Febrile neutropenia	4 (1.3)		7 (2.3)
Neutropenia	3 (1.0)		6 (1.9)
General physical health deterioration	3 (1.0)		6 (1.9)
Pulmonary embolism	6 (1.9)		4 (1.3)

Percentages ( ) were based on N

N number of subjects on intended set, PT preferred term, TEAE treatment-emergent adverse event