Table 3. Treatment-emergent adverse events.

Body system adverse event, n (%)	Temsirolimus (5 mg) (n=17)	Temsirolimus (5 mg)+ketoconazole (400 mg) (n=14)
Any adverse event	12 (71)	8 (57)
Body as a whole
Back pain	1 (5.9)	0
Chills	0	1 (7.1)
Headache	4 (23.5)	2 (21.4)
Neck pain	1 (5.9)	0
Pain	2 (11.8)	0
Cardiovascular system
Syncope	1 (5.9)	0
Tachycardia sinus	1 (5.9)	0
Vascular headache	0	1 (7.1)
Digestive system
Aphthous stomatitis	0	1 (7.1)
Dry mouth	1 (5.9)	0
Dyspepsia	0	1 (7.1)
Mouth pain	1 (5.9)	0
Nausea	0	1 (7.1)
Haemic and lymphatic system
Granulocytosis	1 (5.9)	0
Neutropaenia	3 (17.6)	1 (7.1)
Nervous system
Hostility	0	1 (7.1)
Insomnia	1 (5.9)	0
Nervousness	0	1 (7.1)
Tremor	0	1 (7.1)
Twitching	0	1 (7.1)
Respiratory system
Epitaxis	0	1 (7.1)
Rhinitis	1 (5.9)	0
Skin and appendages
Herpes simplex	1 (5.9)	0
Rash	1 (5.9)	0
Special senses
Visual field defect	0	1 (7.1)
Adverse event associated with miscellaneous factors
Local reaction to procedure	1 (5.9)	0