Table I.

Clinical trials of romiplostim in adults with ITP included in the analysis.

References	Study number	NCT registration*	Study design	Control	Number that received romiplostim
Bussel et al. 9	20000137	00111475	Phase 1	None	24
Bussel et al. 9	20000137	00111475	Phase 2	Placebo	17
Newland et al. 15	20010218	00117143	Phase 1–2	None	16
Shirasugi et al. 17	20050162	00305435	Phase 2	None	12
Newland et al. 16	20080435	01143038	Phase 2	None	75
Kuter et al. 12	20030105	00102323	Phase 3	Placebo	42
Kuter et al. 12	20030212	00102336	Phase 3	Placebo	42
Kuter et al. 14	20060131	00415532	Phase 3	Standard care	156
Shirasugi et al. 19	20060216	00603642	Phase 3	Placebo	22
Janssens et al. 11	20040209	00508820	Phase 3	None	406
Janssens et al. 10	20080009	00907478	Phase 4	None	169
Kuter et al. 13	20030213	00116688	Extension	None	291†
Shirasugi et al. 18	20060113	00440037	Extension	None	44‡
				Total	1046

ITP, immune thrombocytopenia.

^*Registration number at www.clinicaltrials.gov

^†In the open‐label extension study 20030213, n = 238 patients were treated with romiplostim in previous studies, and n = 53 patients received placebo or standard‐of‐care treatment in previous studies and were treated with romiplostim for the first time in this study.

^‡In the open‐label extension study 20060113, n = 11 patients were treated with romiplostim in study 20050162, n = 21 patients were treated with romiplostim in study 20060216 and n = 12 patients received placebo in study 20060216 and were treated for the first time with romiplostim in this study.