Table 3.

Grade 3–4 adverse events during treatment in the PHOTOSTENT-02 trial

Adverse event	PDT+stenting n=46 N (%)	Stenting alone n=46 N (%)	P values
Gamma-glutamyltransferase	28 (61)	22 (48)	0.21
Alkaline phosphatase	22 (48)	17 (37)	0.29
Bilirubin	17 (37)	9 (20)	0.064
Alanine transaminase	4 (9)	6 (13)	0.50
Anaemia	3 (7)	2 (4)	0.65
Albumin	3 (7)	2 (4)	0.65
Biliary sepsis	2 (4)	1 (2)	0.56
Pancreatitis	1 (2)	0 (0)	0.32
Photosensitivity	0 (0)	0 (0)	–
Fever	0 (0)	0 (0)	–
Other toxicity	9 (20)	2 (4)	0.024
Fatigue	2 (4)	0 (0)
Ascites/abdominal bloating	2 (4)	0 (0)
Prothrombin time	2 (4)	0 (0)
Nausea	2 (4)	0 (0)
Sepsis/septicaemia	1 (1)	1 (1)
Cholangitis	1 (1)	0 (0)
Vomiting	0 (0)	1 (1)
Abdominal pain	1 (1)	0 (0)
Urinary retention	0 (0)	1 (1)
Constipation	1 (1)	0 (0)
Insomnia	1 (1)	0 (0)
Somnolence	1 (1)	0 (0)
Any toxicity	39 (85)	30 (65)
Absolute risk difference (95% CI)	19.6% (1.9 to 37.2%)		0.030

PDT, photodynamic therapy.