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. 2020 Jul 7;12:1758835920936932. doi: 10.1177/1758835920936932

Table 1.

Summary of the included studies.

Author/ yearreference Phase of CT Primary site Carry out country Number in intervention/control group ECOG-PS Type of treatment ADE-related outcomes included in analysis
Grothey / 2013 19 III CRC 16 countries in North America, Europe, Asia, and Australia 500/253 0,1 Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle + BSC versus placebo + BSC Dose reductions
Dose interruptions
Permanent discontinuation
Demetri / 2013 20 III GIST 17 countries in North America, Europe, and Asia 132/66 0,1 Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle + BSC versus placebo + BSC Dose reductions
Permanent discontinuation
Li / 2015 21 III CRC China, Hong Kong, South Korea, Taiwan, and Vietnam 136/68 0,1 Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle + BSC versus placebo + BSC Dose reductions
Dose interruptions
Permanent discontinuation
Pavlakis / 2016 22 II GC / GEJ Australia, New Zealand, Canada, Korea 56/29 0,1 Oral regorafenib 160 mg daily on days 1–21 each 28-day cycle + BSC versus oral placebo + BSC Permanent discontinuation
Mir / 2016 23 II STS France, Austria 26/12 0,1 Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle versus placebo Dose reductions
Dose interruptions
Permanent discontinuation
Bruix / 2017 24 III HCC 21 countries in North America, South America, Europe, Asia, and Australia 379/194 0,1 Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle + BSC versus placebo + BSC Dose reductions
Permanent discontinuation
Duffaud / 2019 25 II Osteosarcoma France 89/92 0,1 Oral regorafenib 160 mg once daily on days 1–21 each 28-day cycle + BSC versus placebo + BSC Dose reductions
Dose interruptions
Permanent discontinuation

ADE, adverse drug event; BSC, best supportive care; CRC, colorectal cancer; CT, clinical trial; ECOG-PS, Eastern Cooperative Oncology Group performance status; GC, gastric cancer; GEJ, gastroesophageal junction; GIST, gastrointestinal stromal tumour; HCC, hepatocellular carcinoma; STS, soft tissue sarcoma.