Table 2.
Adverse event not reported (n = 91) | Patient-reported adverse event (n = 58) | |||||||
---|---|---|---|---|---|---|---|---|
SF-36 scalea (Normal scale) | Items | Mean | SD | Alpha* | Mean | SD | Alpha* | P value** |
Physical functioning | 10 | 89.0 | 16.9 | 0.910 | 73.0 | 24.8 | 0.869 | 0.0001 |
Role functioning/physical | 4 | 68.7 | 43.2 | 0.906 | 29.7 | 43.3 | 0.849 | 0.0001 |
Role functioning/emotional | 3 | 64.8 | 46.7 | 0.909 | 22.9 | 39.1 | 0.866 | 0.0001 |
Energy/fatigue | 4 | 58.3 | 16.3 | 0.903 | 48.3 | 17.1 | 0.861 | 0.006 |
Emotional well-being | 5 | 65.3 | 17.8 | 0.902 | 54.8 | 17.1 | 0.851 | 0.005 |
Social functioning | 2 | 78.6 | 22.8 | 0.908 | 59.5 | 16.6 | 0.859 | < 0.0001 |
Pain | 2 | 78.5 | 20.9 | 0.906 | 63.4 | 12.0 | 0.86 | 0.0001 |
General health | 5 | 66.6 | 15.1 | 0.914 | 59.3 | 13.8 | 0.869 | 0.003 |
SF-36 scalea (Norm-based scale) | ||||||||
Physical functioning | 10 | 52.4 | 7.1 | 0.911 | 45.7 | 14.9 | 0.869 | 0.0001 |
Role functioning/physical | 4 | 44.6 | 16.9 | 0.907 | 29.3 | 17.7 | 0.849 | 0.0001 |
Role functioning/emotional | 3 | 39.4 | 21.8 | 0.91 | 19.9 | 18.2 | 0.866 | 0.0001 |
Energy/fatigue | 4 | 50.0 | 8.1 | 0.904 | 44.9 | 8.5 | 0.861 | 0.0005 |
Emotional well-being | 5 | 44.5 | 10.0 | 0.903 | 38.6 | 8.6 | 0.851 | 0.007 |
Social functioning | 2 | 47.5 | 9.9 | 0.909 | 39.2 | 8.1 | 0.859 | 0.0001 |
Pain | 2 | 53.0 | 8.8 | 0.907 | 46.2 | 10.6 | 0.86 | 0.0001 |
General health | 5 | 48.0 | 7.2 | 0.914 | 44.5 | 6.6 | 0.869 | 0.003 |
Mental health component summary (MCS) | 42.2 | 13.0 | n/a | 32.1 | 9.9 | n/a | < 0.001 | |
Physical health component summary (PCS) | 52.8 | 8.2 | n/a | 46.5 | 9.1 | n/a | < 0.0001 |
a using the 36-Item Medical Outcomes Short Form Health Survey (SF-36)
*For the Alpha, Cronbach’ alpha value of >0.80 was used to define good internal consistency of the SF-36 domains
**For the P value, this was to indicate the difference between means for patients with AE vs those without. 0.05 was a cutoff for significance