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Table 1 Fragility index calculated for 6 phase 3 trials with 1:1 randomization for HCC treatment

From: Frequent fragility of randomized controlled trials for HCC treatment

Author Study name Clinical Trial Experimental Treatment vs. Control Endpoint Experimental sample size Experimental event number Control sample size Control event number P vaule Fragility index Fragility quotient
Kudo M et al. [4]. SILIUS NCT01214343 Sorafenib plus HAIC (hepatic arterial infusion chemotherapy) vs. Sorafenib Primary outcome: Overall response 102 37 103 18 0.003 7 3.41%
Wang Z et al. [6]. NA NCT01966133 adjuvant TACE vs. No adjuvant TACE Primary endpoint: Recurrence-free survival 140 46 140 82 0.01 19 6.79%
Lee JH et al. [7]. NA NCT00699816 CIK cell agent vs. No CIK cell agent Primary end point: Recurrence-free survival 114 69 112 59 0.01 0 0%
Llovet JM et al. [8]. SHARP NCT00105443 Sorafenib vs. Placebo Primary endpoint: Overall survival 299 44 303 33 0.00583 0 0%
Wei W et al. [9]. NA NCT02788526 Hepatectomy plus TACE vs. Hepatectomy Primary endpoint: Disease-free survival 116 83 118 85 0.02 0 0%
Geissler EK et al. [10]. NA NCT0035586. Liver transplantation with sirolimus vs. Liver transplantation Secondary endpoint: Overall survival 252 242 256 234   1 0.20%