Appendix Table 2.
Quality of Life analysis: comparison of functional categories by study arm at baseline, mid-study [day 180] and end-of-treatment analyses [day 270].
| Valganciclovir N = 95 Mean (Std) | Placebo N = 89 Mean (Std) | P-value | Difference** (V-P) | 95% CI* | |
|---|---|---|---|---|---|
| Time period 1 (Baseline) | N = 95* | N = 89* | |||
| Physical Functioning | 77.1 (1.8) | 76.4 (2.2) | 0.81 | 0.7 | −4.9, 6.3 |
| Role Functioning | 63 (3.3) | 62.2 (3.4) | 0.86 | 0.8 | −8.5, 10.2 |
| Emotional Functioning | 77.5 (2) | 82.9 (1.6) | 0.037 | −5.4 | −10.5, −0.3 |
| Cognitive Functioning | 77.6 (2.4) | 80.3 (2.1) | 0.41 | −2.7 | −9.1, 3.7 |
| Social Functioning | 59 (2.7) | 57.3 (2.9) | 0.66 | 1.8 | −6.1, 9.7 |
| Global health status / QoL | 60.5 (2.1) | 62.1 (2.2) | 0.59 | −1.7 | −7.8, 4.5 |
| Fatigue | 44.8 (2.8) | 41.6 (2.6) | 0.40 | 3.2 | −4.2, 10.6 |
| Nausea / Vomiting | 12.1 (1.8) | 10.8 (1.9) | 0.61 | 1.4 | −3.9, 6.6 |
| Pain | 21.3 (2.5) | 22.7 (3.0) | 0.72 | −1.4 | −9.2, 6.3 |
| Dyspnea | 18.3 (2.4) | 17.9 (2.4) | 0.91 | 0.4 | −6.3, 7.1 |
| Insomnia | 31.2 (3) | 32.3 (2.9) | 0.78 | −1.2 | −9.4, 7 |
| Appetite loss | 25.9 (3) | 20.1 (2.8) | 0.162 | 5.8 | −2.3, 13.9 |
| Constipation | 3.5 (1.2) | 4.2 (1.4) | 0.70 | −0.7 | −4.2, 2.9 |
| Diarrhea | 14.2 (2.4) | 15.1 (2.6) | 0.79 | −0.9 | −7.8, 6 |
| Financial Problems | 37.5 (3.2) | 41.7 (3.5) | 0.38 | −4.1 | −13.4, 5.2 |
| Time period 2 (Day 180) | N = 84* | N = 80* | |||
| Physical Functioning | 83 (2.1) | 78.8 (2.4) | 0.20 | 4.2 | −2.2, 10.6 |
| Role Functioning | 69.2 (3.3) | 66 (3.6) | 0.49 | 3.3 | −6.1, 12.7 |
| Emotional Functioning | 81.4 (2.2) | 81.4 (2.1) | 0.98 | −0.1 | −6.1, 5.9 |
| Cognitive Functioning | 80.7 (2.5) | 79.9 (2.5) | 0.82 | 0.8 | −6.2, 7.8 |
| Social Functioning | 69.7 (3.5) | 67.9 (3.2) | 0.70 | 1.8 | −7.2, 10.8 |
| Global health status / QoL | 66.4 (2.2) | 64.9 (2.6) | 0.69 | 1.4 | −5.6, 8.5 |
| Fatigue | 36.7 (2.7) | 38.9 (3.0) | 0.56 | −2.2 | −9.7, 5.3 |
| Nausea / Vomiting | 9.1 (1.8) | 12.8 (2.4) | 0.23 | −3.7 | −9.7, 2.3 |
| Pain | 20.5 (3.6) | 22.5 (3.4) | 0.70 | −2.0 | −12, 8.1 |
| Dyspnoea | 16.2 (2.9) | 16.3 (2.8) | 0.97 | −0.1 | −8.2, 7.9 |
| Insomnia | 24.6 (3.4) | 27 (3.2) | 0.62 | −2.3 | −11.6, 7 |
| Appetite loss | 20.4 (3.6) | 21.8 (3.8) | 0.80 | −1.4 | −11.7, 9 |
| Constipation | 5.9 (2.0) | 7.9 (2.3) | 0.51 | −2.0 | −7.8, 3.9 |
| Diarrhea | 12 (2.7) | 10.3 (2.5) | 0.66 | 1.7 | −5.8, 9.2 |
| Financial Problems | 29.4 (4.4) | 38.6 (4.5) | 0.140 | −9.3 | −21.6, 3.1 |
| Time period 3 (Day 270) | N = 75* | N = 77* | |||
| Physical Functioning | 81.2 (2.5) | 82.4 (2.5) | 0.73 | 1.2 | −5.5, 7.9 |
| Role Functioning | 70.1 (3.6) | 67.3 (3.6) | 0.59 | −2.8 | −13.1, 7.5 |
| Emotional Functioning | 85.7 (1.9) | 79.7 (2.2) | 0.051 | −5.9 | −11.9, 0 |
| Cognitive Functioning | 80.7 (2.4) | 82.1 (2.4) | 0.69 | 1.3 | −5.2, 7.9 |
| Social Functioning | 73.9 (3.7) | 74 (3.3) | 0.99 | 0.0 | −10.4, 10.5 |
| Global health status / QoL | 67.2 (2.5) | 65.4 (2.2) | 0.60 | −1.8 | −8.5, 4.9 |
| Fatigue | 33.7 (3.1) | 40.6 (2.9) | 0.111 | 6.9 | −1.6, 15.3 |
| Nausea / Vomiting | 8.4 (2.0) | 7.9 (1.9) | 0.87 | −0.5 | −5.9, 5 |
| Pain | 24.1 (3.8) | 23.3 (3.4) | 0.88 | −0.8 | −11.1, 9.5 |
| Dyspnoea | 16.4 (3.1) | 19.8 (3.3) | 0.46 | 3.4 | −5.6, 12.3 |
| Insomnia | 21 (3.2) | 28.6 (3.7) | 0.134 | 7.6 | −2.4, 17.6 |
| Appetite loss | 12.9 (3.1) | 17.8 (3.9) | 0.34 | 4.9 | −5.3, 15 |
| Constipation | 4.8 (1.7) | 7.3 (2.7) | 0.44 | 2.5 | −3.9, 8.8 |
| Diarrhea | 13.3 (3.0) | 10.5 (2.5) | 0.49 | −2.8 | −10.7, 5.1 |
| Financial Problems | 31.7 (4.7) | 30 (4.3) | 0.79 | −1.7 | −14.5, 11.1 |
*
Includes imputed data for 9 subjects at Time 1, 35 at Time 2 and 29 at Time 3, among those alive and eligible for assessment at each time: 184, 166 and 155 at Times 1, 2 and 3, respectively. Two subjects at Time 2 and 3 at Time 3 were not imputed due to missing Time 1 QoL assessment for the imputation model.