| Time to first hospitalisation or death (n = 568) | Time to first SSc-related hospitalisation or death (n = 570) | Time to first admission to ER or admission to hospital followed by admission to ICU or death (n = 572) |
---|---|---|---|
Longitudinal sub-modela | |||
Estimated slope difference nintedanib vs. placebo (95% CI) | 1.07 (0.10, 2.05) | 1.19 (0.27, 2.12) | 1.18 (0.23, 2.13) |
 P value | 0.03 | 0.01 | 0.02 |
Time to event sub-modelb | |||
 Number of patients with event, n (%) | 103 (18.1) | 56 (9.8) | 90 (15.7) |
Difference in estimated slope of FVC% predicted, HR (95% CI) | |||
 1-unit decrease | 1.14 (1.08, 1.20) | 1.17 (1.09, 1.26) | 1.04 (0.96, 1.13) |
 3-unit decrease | 1.47 (1.25, 1.74) | 1.60 (1.29, 1.98) | 1.12 (0.89, 1.43) |
 5-unit decrease | 1.91 (1.44, 2.51) | 2.18 (1.52, 3.13) | 1.21 (0.82, 1.81) |
 P value | < 0.0001 | < 0.0001 | 0.34 |