Table 2.

Treatment-emergent adverse events (≥15% of any grade in phase 1b or phase 2 in either group) by CTCAE term

	Phase 1b			Phase 2a
	Galunisertib + Gemcitabine (N = 14)			Placebo Group (N = 52)			Galunisertib Group (N = 103)
	Grade 1–2	Grade 3	Grade 4	Grade 1–2	Grade 3	Grade 4	Grade 1–2	Grade 3	Grade 4
Anaemia	5 (36%)	3 (21%)	1 (7%)	19 (37%)	9 (17%)	0	32 (31%)	12 (12%)	0
Neutrophil count decreased	1 (7%)	4 (29%)	2 (14%)	7 (13%)	13 (25%)	1 (2%)	6 (6%)	33 (32%)	3 (3%)
Platelet count decreased	3 (21%)	2 (14%)	1 (7%)	14 (27%)	5 (10%)	1 (2%)	35 (34%)	8 (8%)	0
Nausea	10 (71%)	0	0	16 (31%)	2 (4%)	0	36 (35%)	5 (5%)	0
Vomiting	9 (64%)	0	0	16 (31%)	4 (8%)	0	22 (21%)	4 (4%)	2 (2%)
Constipation	5 (36%)	0	0	14 (27%)	2 (4%)	0	30 (29%)	1 (1%)	0
Abdominal pain	2 (14%)	2 (14%)	0	12 (23%)	3 (6%)	0	28 (27%)	8 (8%)	1 (1%)
Diarrhoea	5 (36%)	1 (7%)	0	12 (23%)	0	0	23 (22%)	0	1 (1%)
Fever	6 (43%)	0	0	11 (21%)	1 (2%)	0	36 (35%)	3 (3%)	0
Oedema limbs	4 (29%)	0	0	11 (21%)	1 (2%)	0	21 (20%)	2 (2%)	1 (1%)
Fatigue	7 (50%)	3 (21%)	0	21 (40%)	5 (10%)	0	41 (40%)	13 (13%)	0
ALT increased	4 (29%)	0	0	2 (4%)	1 (2%)	0	6 (6%)	5 (5%)	0
AST increased	4 (29%)	0	0	2 (4%)	1 (2%)	0	4 (4%)	4 (4%)	0
Anorexia	5 (36%)	0	0	12 (23%)	1 (2%)	0	26 (25%)	4 (4%)	1 (1%)
Hypocalcemia	3 (21%)	0	0	2 (4%)	0	0	4 (4%)	2 (2%)	0
Hypoalbuminemia	5 (36%)	0	0	1 (2%)	0	0	3 (3%)	0	1 (1%)
Headache	5 (36%)	0	0	6 (12%)	0	0	6 (6%)	0	0
Myalgia	4 (29%)	0	0	1 (2%)	0	0	7 (7%)	0	0

^aIn phase 2, Grade 5 events occurred that did not meet the ≥15% threshold; these included: (placebo group) 1 multiorgan failure, 1 peritoneal infection, 1 sepsis, and 1 ascites; (galunisertib group) 2 stroke, 1 pericardial effusion, 1 upper gastrointestinal haemorrhage, 1 infusion related reaction, 1 endocarditis infection, 1 lung infection, 1 arterial injury, and 1 respiratory failure.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; CTCAE=Common Terminology Criteria for Adverse Event