Table 2.

Recorded adverse events^a

	Docetaxel		Docetaxel/gemcitabine		Pb
	Grade 1/2 (%)	Grade 3/4c (%)	Grade 1/2 (%)	Grade 3/4 (%)
Haematological
Neutropenia	0.9	99.1	3.3	95.9	0.21
Leukopenia	11.5	86.7	14.8	84.4	0.62
Anaemia	69.9	0.9	81.1	0.0	0.48
Thrombocytopenia	16.8	0.0	35.2	4.1	0.061
Febrile neutropenia	0.0	27.4	0.0	32.0	0.45
Non-haematological
Irregular or absent menstrual cycle	0.9	98.2	5.7	92.6	0.061
Fatigue	74.3	23.9	77.0	20.5	0.53
Dyspnoea	49.6	21.2	45.9	9.8	0.015
Myalgia	68.1	15.0	72.1	10.7	0.31
Pain	66.4	14.2	68.0	14.8	0.90
Infection, no neutropenia	46.9	11.5	36.1	19.7	0.086
Diarrhoea	62.8	5.3	68.0	1.6	0.16
Oedema	69.9	5.3	66.4	1.6	0.16
Nausea	53.1	4.4	73.8	4.1	0.90
Vomiting	32.7	3.5	29.5	5.7	0.54
Other	73.0	27.0	77.4	22.6	0.59

^aAt least one completed toxicity evaluation form was required for subject inclusion in the safety analysis (235 cases were included). The adverse events are presented by the worst grade of severity encountered during the study.

^bP values denote comparison between grade 3 to 4 adverse events between the groups.

^cOne fatal (grade 5) adverse event was recorded in the docetaxel arm.