Table 4. Laboratory abnormalities per study arm.

	LD-SP/SP			LD-SP/PIP			LD-PIP/PIP			LD-PIP/SP
	N (% of total) of grade 1	N (% of total) of grade 2	N (% of total) of grade 3	N (% of total) of grade 1	N (% of total) of grade 2	N (% of total) of grade 3	N (% of total) of grade 1	N (% of total) of grade 2	N (% of total) of grade 3	N (% of total) of grade 1	N (% of total) of grade 2	N (% of total) of grade 3
Any lab. abnormality	15 (14)	7 (7)	2 (2)	13 (12)	10 (9	3 (3)	16 (15)	9 (8)	2 (2)	13 (12)	8 (8)	8 (8)
Decreased hemoglobin	0	0	0	1 (14)	2 (29)	0	1 (14)	1 (14)	0	1 (14)	1 (14)	0
Decreased WBC	1 (8)	3 (23)	0	1 (8)	2 (15)	0	1 (8)	2 (15)	0	1 (8)	2 (15)	0
Decreased neutrophils	3 (23)	1 (8)	0	2 (15)	0	0	3 (23)	1 (8)	0	3 (23)	0	0
Decreased lymphocytes	3 (20)	1 (7)	0	1 (7)	3 (20)	0	3 (20)	1 (7)	0	1 (7)	2 (13)	0
Decreased platelets	3 (25)	0	0	2 (17)	0	0	4 (33)	0	0	1 (8)	2 (17)	0
Elevated ALT	2 (13)	1 (6)	1 (6)	2 (13)	0	2 (13)	1 (6)	2 (13)	1 (6)	0	0	4 (25)
Elevated AST	1 (7)	1 (7)	1 (7)	2 (13)	1 (7)	1 (7)	1 (7)	2 (13)	1 (7)	0	0	4 (27)
Elevated yGT	1 (11)	0	0	1 (11)	1 (11)	0	2 (22)	0	0	3 (33)	1 (11)	0
Elevated ALP	0	0	0	0	1 (33)	0	0	0	0	2 (67)	0	0
Elevated total bilirubin	1 (50)	0	0	0	0	0	0	0	0	1*(50)	0	0
Elevated creatinine	0	0	0	1 (100)	0	0	0	0	0	0	0	0
Elevated BUN	0	0	0	0	0	0	0	0	0	0	0	0

Number of subjects with the highest grade reported for a laboratory abnormality. Grading based on WHO toxicity grading scale. No grade four abnormalities were reported. Lymphocytes (10⁹/l) were graded based on grade 1: 0.9–0.6; grade 2: 0.3–0.5; grade 3:<0.3.

Liver function tests were graded based on grade 1: 1.1.–2.5X ULN, grade 2: 2.6–5.0x ULN, grade 3:>5.0X ULN. WBC, white blood count; ALT, alanine aminotransferase; AST, aspartate aminotransferase; yGT, glutamyl transpeptidase; ALP, alkaline phosphatase;.

See Figure 6—figure supplement 1 for a detailed overview of liver function test abnormalities.

BUN, blood urea nitrogen. T1, treatment 1; T2, treatment 2.*Subject showed elevated total bilirubin at baseline.