. Author manuscript; available in PMC: 2015 Aug 12.

Published in final edited form as: Qual Life Res. 2014 Feb 4;23(6):1841–1858. doi: 10.1007/s11136-014-0628-5

Table 4.

Comparison of Change in Score from Baseline to Analyzed Time Points Between Treatment Arms

	Change from Baseline to 4 weeks			Change from Baseline to 13 weeks			Change from Baseline to 26 weeks			Change from Baseline to 48 weeks
	GM-CSF (n=42)	Placebo (n=45)	p-value	GM-CSF (n=37)	Placebo (n=40)	p-value	GM-CSF (n=30)	Placebo (n=36)	p-value	GM-CSF (n=22)	Placebo (n=35)	p-value
Individual Questions
General Pain^#	(n=41)	(n=43)		(n=37)	(n=39)		(n=30)	(n=34)		(n=22)	(n=34)
Median	0	0	0.66	0	0	0.57	0	0	0.85	0	10	0.69
Min – Max	−40 – 60	−60 – 60		−60 – 60	−60 – 60		−20 – 60	−40 – 60		−20 – 60	−80 – 80

Mouth Pain^#	(n=40)	(n=42)		(n=34)	(n=37)		(n=29)	(n=35)		(n=22)	(n=34)
Median	0	−20	0.72	0	0	0.38	0	0	0.64	10	0	0.08
Min – Max	−80 – 40	−80 – 60		−60 – 60	−60 – 60		−40 – 60	−80 – 60		−20 – 60	−60 – 40

Throat Pain^#	(n=40)	(n=42)		(n=36)	(n=39)		(n=30)	(n=36)		(n=22)	(n=35)
Median	−20	−20	0.76	0	0	0.59	0	0	0.86	20	0	0.25
Min – Max	−60 – 60	−60 – 40		−80 – 60	−60 – 40		−40 – 60	−40 – 60		−40 – 60	−40 – 80

Disfigurement^#	(n=40)	(n=43)		(n=35)	(n=39)		(n=28)	(n=36)		(n=21)	(n=35)
Median	0	0	0.19	0	0	0.19	0	0	0.56	0	0	0.76
Min – Max	−60 – 80	−60 – 20		−60 – 80	−60 – 40		−80 – 40	−60 – 40		−20 – 40	−60 – 40

Activities^#	(n=42)	(n=45)		(n=37)	(n=37)		(n=30)	(n=35)		(n=22)	(n=35)
Median	−20	0	0.37	−20	−20	0.95	0	0	0.72	0	0	0.36
Min – Max	−60 – 20	−60 – 40		−60 – 40	−40 – 40		−60 – 40	−80 – 40		−60 – 40	−40 – 40

Recreation/Entertainment^#	(n=41)	(n=44)		(n=35)	(n=37)		(n=30)	(n=35)		(n=21)	(n=35)
Median	−20	−20	0.28	0	0	0.68	0	0	0.81	0	0	0.47
Min – Max	−60 – 20	−60 – 40		−80 – 40	−60 – 20		−80 – 40	−80 – 20		−40 – 40	−40 – 20

Employment^#	(n=31)	(n=27)		(n=30)	(n=27)		(n=28)	(n=25)		(n=16)	(n=28)
Median	0	0	0.22	0	0	0.48	0	0	0.65	0	0	0.21
Min – Max	−80 – 60	−80 – 0		−80 – 60	−80 – 80		−80 – 40	−80 – 80		−80 – 20	−60 – 80

Eating-Chewing^#	(n=40)	(n=42)		(n=36)	(n=34)		(n=28)	(n=33)		(n=20)	(n=33)
Median	−20	0	0.80	−20	0	0.72	0	0	0.65	0	0	0.17
Min – Max	−80 – 60	−80 – 20		−80 – 40	−80 – 60		−60 – 60	−80 – 40		−40 – 60	−80 – 60

Eating-Swallowing^#	(n=39)	(n=42)		(n=34)	(n=35)		(n=28)	(n=33)		(n=21)	(n=28)
Median	−20	−20	0.51	−20	−20	0.64	−20	0	0.51	−20	−20	0.92
Min – Max	−80 – 20	−60 – 40		−80 – 40	−80 – 40		−80 – 40	−60 – 60		−60 – 40	−40 – 80

Individual Questions
Amount of Saliva^#	(n=41)	(n=43)		(n=36)	(n=38)		(n=30)	(n=35)		(n=22)	(n=35)
Median	−20	−20	0.26	−20	−40	0.50	−40	−40	0.65	−40	−40	0.69
Min – Max	−60 – 40	−80 – 40		−80 – 60	−80 – 60		−60 – 60	−80 – 60		−80 – 40	−80 – 60

Consistency of Saliva^#	(n=37)	(n=43)		(n=34)	(n=38)		(n=27)	(n=33)		(n=21)	(n=32)
Median	−20	−40	0.75	−30	−20	0.96	−40	−40	0.81	−20	−40	0.25
Min – Max	−80 – 40	−80 – 20		−80 – 20	−80 – 40		−80 – 60	−80 – 20		−80 – 40	−80 – 40

Taste^#	(n=40)	(n=43)		(n=36)	(n=37)		(n=30)	(n=34)		(n=21)	(n=34)
Median	−60	−60	0.62	−40	−40	0.96	−20	−20	0.70	−20	−20	0.73
Min – Max	−80 – 80	−80 – 0		−80 – 20	−80 – 80		−80 – 60	−80 – 80		−60 – 60	−60 – 80

Speech^#	(n=41)	(n=43)		(n=36)	(n=40)		(n=27)	(n=35)		(n=22)	(n=35)
Median	0	0	0.08	0	0	0.36	0	0	0.81	0	0	0.26
Min – Max	−60 – 40	−40 – 0		−60 – 20	−40 – 40		−20 – 20	−20 – 20		−40 – 20	−40 – 20

Amount of Mucous^#	(n=40)	(n=41)		(n=36)	(n=40)		(n=29)	(n=35)		(n=22)	(n=35)
Median	−20	−20	0.05	−20	−40	0.02	−20	−20	0.98	0	−20	0.07
Min – Max	−80 – 80	−80 – 40		−60 – 40	−80 – 40		−80 – 80	−80 – 40		−60 – 80	−60 – 40

Consistency of Mucous^#	(n=41)	(n=42)		(n=36)	(n=40)		(n=27)	(n=36)		(n=22)	(n=35)
Median	−20	−30	0.29	−20	−30	0.11	−20	−20	0.50	−20	−20	0.68
Min – Max	−80 – 60	−80 – 40		−80 – 40	−80 – 40		−80 – 80	−80 – 40		−60 – 60	−80 – 40

Domains^#
Mucous Domain#	(n=40)	(n=39)		(n=36)	(n=40)		(n=27)	(n=35)		(n=22)	(n=35)
Median	−20	−30	0.15	−20	−30	0.04	−20	−20	0.78	−10	−20	0.23
Min – Max	−80 – 70	−70 – 40		−60 – 40	−80 – 40		−70 – 80	−80 – 30		−60 – 70	−60 – 30

Eating Domain#	(n=34)	(n=39)		(n=31)	(n=32)		(n=26)	(n=30)		(n=19)	(n=26)
Median	−32.5	−35	0.94	−30	−32.5	0.95	−30	−25	0.73	−25	−20	0.92
Min – Max	−60 – 15	−65 – 15		−75 – 10	−55 – 5		−50 – 20	−65 – 45		−50 – 20	−55 – 65

Pain Domain#	(n=38)	(n=39)		(n=34)	(n=35)		(n=29)	(n=33)		(n=22)	(n=33)
Median	−6.7	−13.3	0.67	0	−6.7	0.50	6.7	0	0.92	10	6.7	0.14
Min – Max	−60 – 47	−53 – 47		−53 – 47	−60 – 33		−33 – 47	−47 – 53		−27 – 47	−47 – 53

Domains^#
Activities Domain#	(n=41)	(n=44)		(n=35)	(n=36)		(n=30)	(n=34)		(n=21)	(n=35)
Median	−20	−10	0.22	−10	−10	0.84	−5	0	0.72	−10	0	0.78
Min – Max	−60 – 10	−50 – 30		−70 – 20	−50 – 30		−70 – 40	−80 – 30		−50 – 40	−40 – 30

Total
Total Score	(n=30)	(n=29)		(n=28)	(n=26)		(n=25)	(n=26)		(n=18)	(n=26)
Mean	−20.5	−19.4	0.77^§	−18.4	−20.8	0.47^§	−14.0	−11.9	0.58^§	−6.8	−11.6	0.30^§
SD	14.6	14.1		11.9	13.1		11.8	14.8		15.0	14.9

P-value from two-sided Wilcoxon-Mann-Whitney Test using the normal approximation.

^§

P-value from two-sided t-test assuming equal variances.

To adjust for multiplicity while accounting for the correlated nature of the items and domains, p<0.01 was considered significant domains and individual items.

Change scores were calculated by subtracting the follow-up assessment from baseline (baseline – follow-up). Therefore, a negative change score corresponds to increased symptom burden at follow-up.