Table 2.

Efficacy assessment of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma, carried out by the Independent Review Committee (response‐evaluable population, n = 16)

Parameter	Statistics, n = 16
Primary end‐point
Best overall response, n (%)
CR	2 (12.5)
PR	12 (75.0)
SD	2 (12.5)
PD	0 (0.0)
ORR (CR or PR)	14 (87.5)
Exact 90% CI	(65.6–97.7)
Secondary end‐points
Duration of response, months, n (%)
Responder (CR or PR)	14
Progressed or died, event	2 (14.3)
Censored	12 (85.7)
Median (95% CI)	NE (2.79–NE)
Range	(1.1–6.4+)
3‐months duration rate (95% CI)	0.83 (0.47–0.96)
6‐months duration rate (95% CI)	0.83 (0.47–0.96)
Time to initial response,† months
Responder (CR or PR)	14
Median	1.84
Range	0.7–5.3
Time to CR,‡ months
Responder (CR)	2
Median	2.84
Range	1.8–3.8
Progression‐free survival, months, n (%)
Progressed or died, event	2 (12.5)
Censored	14 (87.5)
Median (95% CI)	NE (NE–NE)
Range	(2.8–8.0+)
6‐months PFS rate (95% CI)	0.88 (0.59–0.97)

†Derived for subjects who achieved complete response (CR) or partial response (PR). ‡Derived for subjects who achieved CR. +, Censored observation; CI, confidence interval; PD, progressive disease; ORR, overall response rate; NE, not estimable; PFS, progression‐free survival.