Biocurcumin as Radiosensitiser for Cervical Cancer Study (BRACES): A Double-Blind Randomised Placebo-Controlled Trial

Table 8

Adverse events during treatment.

Adverse event	BCM-95 (n = 60)	Placebo (n = 57)	value RR CI 95%
Summary of adverse event
Overall adverse event	18 (30%)	14 (24.5%)	0.47
			1.08 (0.87–1.3)
Serious adverse event	6 (10%)	3 (5.2%)	0.33
			0.5 (0.13–1.9)
Death	2 (3.33%)	2 (3.5%)	0.97
			1.03 (0.15–7.09)
Most common adverse event
Gastrointestinal nausea/vomiting	18 (30%)	14 (24.5%)	0.47
			1.08 (0.87–1.3)
Stomatitis	12 (20%)	15 (25%)	0.45
			1.2 (0.6–2.5)
Diarrhea	2 (3.33%)	0	0.16
			1 (1.00372–1.00377)
Liver
Increase AST	3 (5%)	2 (3.3%)	0.67
			0.68 (0.11–3.9)
Increase ALT	3 (5%)	0	0.08
			1 (0.01–0.14)
Kidney
Increase creatinine	3 (5%)	1 (1.6%)	0.35
			0.3 (0.03–3.2)
Hematuria	0	0
Skin
Dermatitis	0	0