Table II.

Comparison of the joint model versus the separate analysis for %FVC measurements alone using 6–12 month SLS data.

	Joint analysis		Separate analysis
	Estimate (SE)	p-value	Estimate (SE)	p-value
Longitudinal outcome %FVC
Baseline %FVC (β1)	0.96 (0.02)	<0.0001	0.96 (0.04)	<0.0001
Fibrosis (β2)	−1.66 (0.50)	0.001	−1.69 (0.85)	0.05
CYC group (β3)	−2.26 (1.50)	0.13	−2.51 (2.43)	0.30
CYC × Fibrosis (β4)	1.79 (0.66)	0.006	1.83 (1.11)	0.10
Effect of CYC (H0 : β3 = β4 =0)*		0.001		0.13
Cause-specific probability (treatment failure or death)
Baseline %FVC (α1)	−0.10 (0.14)	0.49	−0.03 (0.13)	0.83
Fibrosis (α2)	−0.45 (1.47)	0.76	0.30 (1.39)	0.83
CYC group (α3)	0.91 (6.71)	0.89	−0.86 (7.56)	0.91
CYC × Fibrosis (α4)	0.01 (2.82)	1.00	0.32 (3.30)	0.92
Effect of CYC (H0 : α3 = α4 = 0)*		0.93		0.99
Conditional cause-specific hazards (time to treatment failure or death)
Baseline %FVC (γ11)	0.01 (0.06)	0.85	0.04 (0.26)	0.87
Fibrosis (γ12)	0.001 (0.88)	1.00	−0.46 (2.88)	0.87
CYC group (γ13)	−0.34 (3.30)	0.92	2.72 (9.09)	0.76
CYC × Fibrosis γ14)	−0.28 (1.52)	0.85	−1.49 (3.68)	0.68
Effect of CYC (H0 : γ13 = γ14 = 0)*		0.64		0.86
Conditional cause-specific hazards (time to disease-related dropout)
Baseline %FVC (γ21)	−0.05 (0.05)	0.25	−0.01 (0.05)	0.76
Fibrosis (γ22)	0.24 (0.75)	0.75	0.45 (0.58)	0.44
CYC group (γ23)	1.61 (3.03)	0.60	1.06 (1.46)	0.47
CYC × Fibrosis (γ24)	−0.41 (1.27)	0.75	−0.36 (0.62)	0.56
Effect of CYC (H0 : γ23 = γ24 = 0)*		0.75		0.75

^*The p-values are based on Wald test with 2 degrees of freedom.