Table 5.

Longitudinal variations of primary and secondary end points.

	Quality of life score	Difference from baseline [95% C.I.]
Screening	67.8 ± 9.4	–
Visit 1	73.6 ± 11.9	5 [−0.5 to 10.7] p = 0.092
Visit 2	78.9 ± 11.1	10.4 [4.8 to 16] p < 0.001
Visit 3	75.3 ± 9.2	6.8 [1.2 to 12.5] p = 0.025
Visit 4	74 ± 9.5	5.5 [−0.1 to 11.1] p = 0.069
	Adverse events score	Difference from baseline [95% C.I.]
Screening	55.5 ± 17.9	–
Visit 1	68.2 ± 17.1	12.4 [2.6 to 22.3] p = 0.02
Visit 2	67.4 ± 17.9	11.6 [1.8 to 21.5] p = 0.029
Visit 3	76.7 ± 8.2	20.8 [11 to 30.7] p < 0.001
Visit 4	74.8 ± 9.1	18.9 [9.1 to 28.8] p < 0.001
	Fatigue	Difference from baseline [95% C.I.]
Screening	30.9 ± 8.1	–
Visit 1	35.5 ± 7.2	4.8 [0.8 to 8.8] p = 0.027
Visit 2	36.9 ± 9	6.2 [2.2 to 10.2] p = 0.005
Visit 3	40.3 ± 4.9	9.6 [5.6 to 13.6] p < 0.001
Visit 4	37.5 ± 8.3	6.8 [2.8 to 10.8] p = 0.002
	Functional well-being	Difference from baseline [95% C.I.]
Screening	14.5 ± 5.4	–
Visit 1	15 ± 4.8	0.2 [−2.4 to 2.8] p = 0.873
Visit 2	15.2 ± 4.9	0.5 [−2.1 to 3.1] p = 0.731
Visit 3	15 ± 3.7	0.2 [−2.4 to 2.8] p = 0.873
Visit 4	13.3 ± 2.9	−1.4 [−4 to 1.2] p = 0.288
	Emotional well-being	Difference from baseline [95% C.I.]
Screening	17 ± 3.4	–
Visit 1	18.4 ± 3.7	1.3 [−0.4 to 3.1] p = 0.157
Visit 2	19.1 ± 2.5	2 [0.2 to 3.8] p = 0.036
Visit 3	18.7 ± 3.9	1.6 [−0.2 to 3.4] p = 0.094
Visit 4	18.7 ± 3.2	1.6 [−0.2 to 3.4] p = 0.094
	Social/family well-being	Difference from baseline [95% C.I.]
Screening	20.1 ± 4.1	–
Visit 1	20.1 ± 3	−0.3 [−2.8 to 2.3] p = 0.847
Visit 2	22 ± 4.8	1.7 [−0.9 to 4.3] p = 0.225
Visit 3	18.8 ± 4.6	−1.5 [−4.1 to 1.1] p = 0.267
Visit 4	19.5 ± 5.4	−0.8 [−3.4 to 1.8] p = 0.533
	Physical well-being	Difference from baseline [95% C.I.]
Screening	17.5 ± 4.6	–
Visit 1	20.1 ± 5.7	2.5 [0 to 5.1] p = 0.064
Visit 2	22.6 ± 3.7	5 [2.5 to 7.6] p < 0.001
Visit 3	22.8 ± 3.6	5.3 [2.7 to 7.8] p < 0.001
Visit 4	22.5 ± 2.4	4.9 [2.4 to 7.5] p < 0.001

Changes from baseline, with the corresponding 95%C.I., were obtained using linear mixed models.