Table 3.

Adverse effects (intention-to-treat sample)

Adverse effects	Miltefosine group (n = 78)	Combination therapy group (n = 66)	P-value
Constitutional
Fever, grade 1	6 (7.7%)	63 (95.5%)	< 0.001
Rigors, grade 1	0	63 (95.5%)	< 0.001
Insomnia	12 (15.9%)	5 (7.6%)	0.197
Metabolic (raised creatinine)
Grade 2	0	2 (3.0%)	0.21
Grade 3	3 (3.9%)	1 (1.5%)	0.625
Total	3 (3.9%)	3 (4.6%)	1.0
Seizure
Grade 1	1 (1.9%)	0	1.0
Gastrointestinal
Vomiting
Grade 1	30 (38.5%)	54 (81.8%)	< 0.001
Grade 2	21 (26.9%)	0	< 0.001
Grade 3	9 (11.5%)	0	0.004
Total	60 (76.9%)	54 (81.8%)	0.24
Diarrhea
Grades 1 and 2	0	0
Grade 3	1 (1.9%)	0	1.0
Total	1 (1.9%)	0	1.0
Epistaxis, grade 1	9 (11.5%)	0	0.004
Pain in the abdomen, not otherwise specified
Grade 1	17 (21.8%)	0	< 0.001
Grade 3	1 (1.9%)	0	1.0
Total	18 (23.1%)	0	< 0.001