Table 3.
Least squares estimates of fatigue and sleepiness at each time and post-randomization treatment differences
| Outcome | Time | Armodafinil | Control | Difference in LS Mean (90% CI) |
|---|---|---|---|---|
| LS Mean (SE) | LS Mean (SE) | |||
| FACIT-Fatigue | Baseline | 36.2 (1.55) | 36.2 (1.55) | — |
| EndRT | 30.9 (2.74) | 32.1 (2.56) | −1.25 (−7.28 to 4.78) | |
| 4wpRT | 32.0 (2.56) | 36.0 (2.52) | −3.99 (−9.86 to 1.88) | |
| BFI | Baseline | 2.97 (0.32) | 2.97 (0.32) | |
| EndRT | 3.88 (0.58) | 3.97 (0.54) | −0.10 (−1.38 to 1.18) | |
| 4wpRT | 3.71 (0.57) | 3.29 (0.55) | 0.42 (−0.85 to 1.69) | |
| ESS | Baseline | 7.72 (0.59) | 7.72 (0.59) | |
| EndRT | 7.70 (1.02) | 8.24 (0.92) | −0.54 (−2.77 to 1.70) | |
| 4wpRT | 7.26 (1.03) | 8.37 (1.00) | −1.11 (−3.47 to 1.26) | |
| Greater fatigue at baseline | ||||
| FACIT-Fatigue | Baseline | 27.1 (1.89) | 27.1 (1.89) | — |
| EndRT | 31.5 (2.53) | 23.2 (3.28) | 8.24 (2.16–14.3) | |
| 4wpRT | 31.9 (3.45) | 28.3 (5.10) | 3.62 (−6.56 to 13.8) | |
| Lesser fatigue at baseline | ||||
| FACIT-Fatigue | Baseline | 44.7 (0.77) | 44.7 (0.77) | — |
| EndRT | 24.9 (4.74) | 38.8 (3.15) | −13.9 (−23.6 to −4.11) | |
| 4wpRT | 29.2 (3.92) | 41.4 (2.77) | −12.2 (−20.4 to −4.02) | |
Abbreviations: 4wpRT, 4 weeks post radiation therapy; BFI, Brief Fatigue Inventory; CI, confidence interval; EndRT, end of radiation therapy assessment; ESS, FACIT, Functional Assessment of Chronic Illness Therapy; LS, least squares; SE, standard error Epworth Sleepiness Scale.
Lower scores in the FACIT-Fatigue indicate worse symptoms, while higher scores in the BFI and ESS indicate worse symptoms.