Table 3.

Adverse events during the maintenance phases.

	Maintenance chemo + CHMF (N = 31) n (%)			Maintenance chemo + Placebo (N = 22) n (%)
	Grade 1/2	Grade 3	Any	Grade 1/2	Grade 3	Any
Fatigue	28 (90.3%)	0	28 (90.3%)	22 (100%)	0	22 (100%)
Loss of appetite	15 (48.4%)	0	15 (48.4%)	16 (72.7%)	0	16 (72.7%)
Dry mouth	10 (32.3%)	0	10 (32.3%)	11 (50%)	0	11 (50%)
Leucopenia	8 (25.8%)	0	8 (25.8%)	2 (9.1%)	2 (9.1%)	4 (18.2%)
Nausea	8 (25.8%)	0	8 (25.8%)	6 (27.3%)	0	6 (27.3%)
Vomiting	5 (16.1%)	0	5 (16.1%)	1 (4.5%)	0	1 (4.5%)
Neutropenia	4 (12.9%)	1 (3.2%)	5 (16.1%)	2 (9.1%)	2 (9.1%)	4 (18.2%)
Elevated GGT	4 (12.9%)	0	4 (12.9%)	1 (4.5%)	1 (4.5%)	2 (9.1%)
Anemia	3 (9.7%)	0	3 (9.7%)	2 (9.1%)	1 (4.5%)	3 (13.6%)
ALT/AST increased	3 (9.7%)	0	3 (9.7%)	6 (27.3%)	0	6 (27.3%)
Arhythmia	3 (9.7%)	0	3 (9.7%)	0	1 (4.5%)	1 (4.5%)
Pain	3 (9.7%)	0	3 (9.7%)	4 (18.2%)	0	4 (18.2%)
Elevated cRE	2 (6.5%)	0	2 (6.5%)	0	0	0
Alopecia	2 (6.5%)	0	2 (6.5%)	1 (4.5%)	0	1 (4.5%)
Thrombocytopaenia	1 (3.2%)	0	1 (3.2%)	3 (13.6%)	0	3 (13.6%)
Elevated ALP	1 (3.2%)	0	1 (3.2%)	0	0	0
Elevated TB	1 (3.2%)	0	1 (3.2%)	0	0	0
Proteinuria	1 (3.2%)	0	1 (3.2%)	1 (4.5%)	0	1 (4.5%)
Weight-decrease	1 (3.2%)	0	1 (3.2%)	1 (4.5%)	0	1 (4.5%)
Constipation	1 (3.2%)	0	1 (3.2%)	2 (9.1%)	0	2 (9.1%)
Diarrhea	1 (3.2%)	0	1 (3.2%)	3 (13.6%)	0	3 (13.6%)
Pruritus	1 (3.2%)	0	1 (3.2%)	1 (4.5%)	0	1 (4.5%)
Esthesionosis	1 (3.2%)	0	1 (3.2%)	0	0	0
Rash	0	0	0	1 (4.5%)	0	1 (4.5%)
Haemoptysis	0	0	0	1 (4.5%)	0	1 (4.5%)

Values are expressed as numbers (percentage). Table presents grade 1/2 and 3 adverse events in all patients during the maintenance phases. Adverse events are listed in descending order of frequency in the total patient population. ALT, alanine aminotransferase. AST, aspartate aminotransferase. GGT, γ-glutamyltransferase; CRE, serum creatinine; ALP, alkaline phosphatase; TB, total bilirubin.