Table 4.
Absolute and percentage change from baseline in heart-failure-specific quality of life measured using the Kansas City Cardiomyopathy Questionnaire
| Week 4 |
Week 12 |
Week 24 |
||||
|---|---|---|---|---|---|---|
| FCM (n= 304) | Placebo (n= 155) | FCM (n= 304) | Placebo (n= 155) | FCM (n= 304) | Placebo (n= 155) | |
| HRQoL: KCCQ | ||||||
| Missing data, n (%) | 27 (8.9) | 15 (9.7) | 18 (5.9) | 11 (7.1) | 18 (5.9) | 10 (6.5) |
| Overall summary score, mean ± SEM (% change from baseline) | 9.4 ± 0.9 (33.6 ± 5.2)*** | 3.5 ± 1.2 (10.6 ± 3.3) | 12.2 ± 1.1 (41.9 ± 5.8)*** | 4.6 ± 1.4 (16.1 ± 5.4) | 12.8 ± 1.3 (43.9 ± 6.1)*** | 6.2 ± 1.5 (21.5 ± 6.7) |
| Clinical summary score, mean ± SEM (% change from baseline) | 9.3 ± 0.9 (29.9 ± 4.3)*** | 2.7 ± 1.2 (7.0 ± 2.5) | 11.6 ± 1.1 (36.2 ± 4.7)*** | 3.3 ± 1.4 (9.4 ± 3.5) | 11.4 ± 1.3 (36.8 ± 4.9)*** | 4.2 ± 1.5 (12.6 ± 3.7) |
| Total symptom score, mean ± SEM (% change from baseline) | 10.4 ± 1.0 (34.1 ± 5.1)*** | 3.1 ± 1.2 (7.5 ± 2.6) | 12.7 ± 1.2 (38.0 ± 4.4)*** | 3.3 ± 1.5 (8.2 ± 3.3) | 12.0 ± 1.3 (36.3 ± 4.5)*** | 3.9 ± 1.6 (11.5 ± 3.5) |
| Physical limitation, mean ± SEM (% change from baseline) | 8.2 ± 1.1 (31.7 ± 4.7)*** | 2.3 ± 1.4 (9.8 ± 3.7) | 10.5 ± 1.3 (39.5 ± 5.9)*** | 3.3 ± 1.6 (11.8 ± 4.2) | 10.7 ± 1.5 (45.5 ± 7.1)** | 4.5 ± 1.8 (13.5 ± 4.1) |
| Symptom frequency, mean ± SEM (% change from baseline) | 10.1 ± 1.1 (40.9 ± 8.8)*** | 4.1 ± 1.4 (12.2 ± 3.4) | 12.0 ± 1.2 (44.2 ± 7.9)*** | 3.2 ± 1.5 (10.2 ± 3.9) | 11.5 ± 1.4 (41.4 ± 8.1)*** | 4.6 ± 1.7 (17.6 ± 4.6) |
| Symptom stability, mean ± SEM (% change from baseline) | 12.7 ± 1.4 (32.3 ± 3.3)*** | 1.6 ± 1.9 (8.9 ± 4.4) | 14.2 ± 1.7 (37.6 ± 3.9)*** | 1.7 ± 2.1 (11.6 ± 5.4) | 13.2 ± 1.7 (33.8 ± 3.7)*** | 4.5 ± 2.1 (17.0 ± 5.4) |
| Symptom burden, mean ± SEM (% change from baseline) | 10.8 ± 1.1 (35.2 ± 5.2)*** | 2.1 ± 1.3 (6.1 ± 2.7) | 13.3 ± 1.2 (40.8 ± 5.1)*** | 3.3 ± 1.6 (9.2 ± 3.6) | 12.5 ± 1.4 (39.0 ± 5.1)*** | 3.3 ± 1.7 (10.2 ± 3.6) |
| Self-efficacy, mean ± SEM (% change from baseline) | 6.9 ± 1.3 (23.5 ± 4.3) | 5.7 ± 1.9 (23.0 ± 7.4) | 8.9 ± 1.3 (28.8 ± 4.8)* | 4.3 ± 2.4 (21.3 ± 7.4) | 9.7 ± 1.5 (30.0 ± 5.0) | 6.0 ± 2.4 (26.3 ± 7.8) |
| Quality of life, mean ± SEM (% change from baseline) | 8.7 ± 1.1 (36.8 ± 5.8)** | 3.6 ± 1.6 (19.8 ± 7.1) | 13.3 ± 1.3 (54.9 ± 7.0)*** | 4.5 ± 1.6 (21.7 ± 6.9) | 14.8 ± 1.4 (59.1 ± 7.3)*** | 6.8 ± 1.8 (31.8 ± 8.8) |
| Social limitation, mean ± SEM (% change from baseline) | 10.2 ± 1.4 (46.6 ± 8.5)** | 4.1 ± 1.7 (15.0 ± 5.3) | 12.1 ± 1.6 (55.2 ± 11.0)* | 7.2 ± 2.1 (25.4 ± 7.1) | 13.1 ± 1.7 (54.4 ± 9.7) | 8.5 ± 2.2 (27.5 ± 6.9) |
KCCQ overall summary score data were previously published, and are included here for context.16
*P< 0.05; **P< 0.01; ***P< 0.001 for ferric carboxymaltose vs. placebo.